central nervous system

ALSO NOTED: Novartis buys bigger stake in Alnylam; FDA chastises ZymoGenetics' marketing campaign;and much more...

Thu, 08 May 2008 06:59:50 -0400

> Novartis has scooped up a bigger share of Alnylam stock. The pharma giant now owns 13.3 percent of the company. Alnylam release

> Curious how the FDA might spend its PDUFA fees? A new five-year plan shows that FDA will plow the money into post-marketing safety to meet its commitments under the new law passed last fall. FDA report

> The FDA has chastised ZymoGenetics' maiden effort to commercialize a therapy, saying that its claims for a genetically engineered form of Thrombin are "false or misleading." ZymoGenetics' marketing material notes that the drug has a lower level of antibody formation compared to a competitor, creating the impression that bovine thrombin's antibodies are less safe. Story

> Genzyme has expressed an interest in setting up an Israeli biotech incubator. Report

> Proteome Sciences said it has won a grant of €571,000 to study the proteomics end of a new generation of in-vitro assays. Report

> Did GlaxoSmithKline try to monopolize the Wellbutrin market? A lawsuit now certified as class-action says so. GSK report

> Will today's Congressional hearing on drug ads lead to new legislation? That's what Michigan Democrat--and vocal pharma critic--Bart Stupak hopes. DTC report

> New CEOs often clean house. Biovail's Bill Wells looks like he's trying to gut and rebuild it. The company announced it would shutter two plants in Puerto Rico as it shifts focus to specialize in central nervous system meds, "a market where unmet medical needs and growth potential are high," Wells said. Biovail report

> Merck's layoffs have inspired one newly unemployed poet to write in verse. Report

And Finally… Vaccine experts are pondering just how long vaccines will be able to provide immunity in a world where some diseases are all but eliminated and natural exposure to many common viruses has ended. Vaccine report

Emerging Drug Developer: BrainCells

Mon, 10 Mar 2008 07:59:59 -0400

BrainCells

Remember when they used to say that you'd have all the brain cells you ever could have when you reached adulthood?

Turns out, they were wrong.

San Diego-based BrainCells has set out to find existing drugs that can spur the development of new neural stem cells, building on research that demonstrates that the process can have a therapeutic effect on a host of diseases of the central nervous system, including major-market targets like depression, anxiety and schizophrenia. And its platform technology is geared to spotlight the most likely drug candidates from a slate of therapies that have pushed past early-stage safety trials for other indications--a strategy that allows researchers to advance swiftly into mid-stage trials while striking up new research and development pacts with other biotech companies.

That's proven to be a winning argument for a high-profile group of venture funds. This morning BrainCells will announce its second round of $30 million, with MedImmune Ventures joining Bay City Capital, Oxford Bioscience Partners, Technology Partners, Pappas Ventures and Neuro Ventures in the round. Their money goes to the mid-stage development of BrainCells' lead candidate--BCI-540--and the hunt for more therapies that can advance quickly into Phase II. Article

Q Therapeutics raises $15M

Fri, 15 Feb 2008 06:59:55 -0500

Salt Lake City-based Q Therapeutics has raised $15 million in a second round of financing. The company is developing cell-based therapies for the central nervous system. It is currently running preclinical studies and hopes to file an IND for a treatment for transverse myelitis, a rapidly paralyzing subset of multiple sclerosis. Q expects clinical trials to begin in 2009. VSpring Capital led the round, and Invitrogen was among a group of investors that also participated.

"This investment will help accelerate our efforts to bring important new treatments to the clinic for these extremely debilitating neurodegenerative diseases. As a leader in providing many of the necessary tools for stem cell research and production, Invitrogen's participation will further enhance our development going forward."

- see this release for more

Related Articles:
Invitrogen puts up $57M for CellzDirect buyout. Report

Valeant shares jump on epilepsy trial data

Wed, 13 Feb 2008 06:59:54 -0500

Shares of Valeant Pharma jumped yesterday after the developer announced that its experimental epilepsy treatment retigabine met its primary endpoint in reducing the number of seizures by a statistically significant margin. Data from a second late-stage trial is expected in the second quarter of this year with an NDA expected in the U.S. and Europe by the end of this year.

"These data confirm the efficacy seen with retigabine in earlier clinical trials and put Valeant at the forefront of development of neuronal potassium channel openers for the treatment of epilepsy and other central nervous system diseases," says Michael Pearson, Valeant's chairman and chief executive officer.

- here's the release
- read the AP report

Related Articles:
Valeant sells development programs. Report
Valeant hep C drug fails pivotal trial, again. Report
Valeant to out-license programs in restructuring. Report

ALSO NOTED: Dynogen goes public; Alpharma sells ingredients unit for $395M; Arizona launches new venture fund; and much more...

Wed, 06 Feb 2008 06:59:50 -0500

> Dynogen Pharmaceuticals is going public in a buyout deal with Apex Bioventures Acquisition Corp. Dynogen shareholders will initially receive $98 million in the deal, with Dynogen merging with a subsidiary of Apex. Dynogen will be left with about $65 million in cash on hand for development work. Dynogen has been focused on irritable bowel syndrome, nocturnal gastroesophageal reflux disease and overactive bladder. Release

> Alpharma plans to sells its active pharmaceutical ingredients unit to 3i for $395 million and use the proceeds to grow its drug and animal health business. Release

> A group of Arizona biotech leaders has created the state's first venture fund for early-stage developers. Translational Accelerator gets started with $20 million for the biotech field, with the money slated for developers either in the state or coming to the state. Companies engaged in research for cancer and central nervous system diseases and diagnostics can qualify for loans of $500,000 to $2 million. Report

> Investor Carl Icahn (photo), who has specialized recently in upending several biotech companies, says he's planning to start blogging about some of his favorite issues, like executive compensation. Report

> Researchers are focusing on a more efficient method for breeding transgenic animals to produce proteins. Report

> The FDA has agreed to review UCB's Cimzia for rheumatoid arthritis. Report

> Cook Pharmica, a contract manufacturer, is planning an $80 million expansion of its Bloomington, IN plant. Report

> MethylGene and EnVivo Pharmaceuticals today announced that MethylGene has exercised its right to opt-out of further funding in its collaboration with EnVivo signed in February 2005. Release

> Biogen Idec reported a surge in profits in the fourth quarter as revenue from its two biggest therapies--Rituxan and Avonex--spiked. Report

> Puerto Rico is the birthing center for 13 of the 20 top-selling drugs in the U.S., but plants there have had repeated quality-control problems, according to an investigation by the Associated Press. Report

> The UK's Wellcome Trust says it will pump up its research spending by 60 percent over the next five years as it ambitiously seeks a better understanding of diseases at a genetic level. Report

> Reporters took Fosamax's patent expiration today as an opportunity to remind us all that 20 billion worth of drugs will go off patent this year, cutting big-time into Big Pharma's sales. Report

> Think before you click. That's the moral of today's tale, the story of a lawyer, a reporter and a $1 billion potential settlement that Eli Lilly wanted to keep quiet--but ended up all over the news. Report

And Finally... DNA from the Black Rat can be used to show how diseases have spread around the globe. Release

Lilly snares MS drug rights in $497M deal

Tue, 18 Dec 2007 06:59:57 -0500

Analysts applauded Canada's BioMS after it scored a rich licensing deal with Eli Lilly. Lilly gains commercialization rights in exchange for a whopping $87 million up-front fee and milestones reaching up to $410 million. One analyst called BioMS's MBP8298 the most advanced therapy in the clinic for secondary progressive multiple sclerosis. Both companies will share some development costs, with Lilly responsible for worldwide marketing.

"MBP8298 has shown potential in slowing the progression of secondary progressive MS, and thus may provide an effective therapeutic option for patients with this debilitating disease," said Dr. William W. Chin, M.D., vice president of discovery research and clinical investigation for Lilly. "We are also hopeful that MBP8298 may prove beneficial in treating patients with relapsing remitting MS."

- here's the release
- check out the report from the Globe and Mail

ALSO: Ambrx has inked a collaboration deal with Eli Lilly to develop new treatments in metabolic diseases, central nervous system disorders and other diseases. The numbers are being kept under wraps. Release

PLUS: There are big changes afoot at Eli Lilly. The company says that it has named John C. Lechleiter (photo) it's CEO to lead it through what many analysts say will be sorely troubled times. Report

Related Articles:
Lilly predicts double-digit earnings growth. Report
Eli Lilly to outsource half of research by 2010. Report
New guard takes over Big Pharma. Report

ALSO NOTED: Osgood promoted at ThermoGenesis; ImClone expects CEO announcement; OVATION expands pipeline; and much more...

Tue, 31 Jul 2007 06:59:50 -0400

> ThermoGenesis has promoted COO William Osgood to the CEO's post. The transition was triggered by founder Phil Coelho's move to the new position of chief technology architect. Report

> ImClone said it expects to name a new CEO within a month as net income slid on flat revenue. Report

> Ovation Pharmaceuticals has expanded its central nervous system development pipeline with the initiation of a pivotal clinical trial to support a new drug application of intravenous carbamazepine in adult patients with epilepsy. Release

And Finally... A new study attempts to explain what motivates feelings of guilt. Report

Press Release: Roche Continues to Strengthen Research and Development Focus

Maureen Martino — Mon, 05 Feb 2007 11:09:13 -0500

Roche Continues to Strengthen Research and Development Focus on Disease Biology Areas to Enhance Alignment of R&D

BASEL, Switzerland, Feb. 5, 2007 -- Today Roche announced that it will be introducing a new operating model for its global research and development (R&D) activities, organised around Disease Biology Areas (DBA). Each DBA will cover the whole range of activities - from R&D to strategic marketing - in a specific therapeutic field. The Disease Biology Area Leadership Teams (DBLTs) will be co-located in Basel, Nutley and Palo Alto. In an integrated approach, they will seamlessly manage compounds from drug discovery through to medical proof of concept, with oversight through to the market. Roche's R&D efforts continue to focus on clinically differentiated medicines. DBAs will be created for the following five therapeutic areas: - Oncology, DBLT based in Nutley, New Jersey, USA - Virology, DBLT based in Palo Alto, California, USA - Inflammation, DBLT based in Palo Alto, California, USA - Metabolism, DBLT based in Basel, Switzerland - Central nervous system, DBLT based in Basel, Switzerland

This new model is designed to ensure that Roche's steadily expanding R&D operation is suitably equipped to meet increasingly complex requirements. By simplifying and accelerating the multiple decision-making processes involved, the model will be more efficient and effective in translating research activity in each therapeutic area into clinically differentiated medicines. It will also enable the Group's growing number of development projects to be integrated more quickly.

As innovation continues to be at the core of its activities, the Roche Group expects further increases in 2007 and beyond, not only in R&D staff numbers but also in its R&D budget, currently running at approximately 6 billion Swiss francs ($4.8bn).

"Innovation and the creativity of our people will remain the basis of our success", says Roche Chairman and CEO, Franz B. Humer. "We have significantly increased our investments in R&D over past years and will continue to do so. By combining existing expertise in Disease Biology Areas, we will further enhance the optimal conditions for bringing future innovations to fruition faster and more efficiently - with clear benefits for patients and doctors".

Research sites around the world In addition to Basel, Nutley and Palo Alto, all other current research sites in the Roche network will continue to play an important role in creating innovation. Therapeutic protein research will be intensified at the Penzberg site in Germany, and in Shanghai, China, Roche will expand its R&D activities, supporting the DBAs world wide. Indeed the wide variety of functional experience will continue to support our endeavours across the company.

Alignment of therapeutic areas Each of the five DBAs will be managed by a cross-functional leadership team with representatives from Discovery, Clinical Research and Exploratory Development, Clinical Development and Strategic Marketing co-located at one site. In their own therapeutic areas these teams will decide which medicines to develop and along which most efficient path. The five teams will report to the newly created Strategic Portfolio Committee, which is made up of senior Pharma Division managers.

"We're taking the opportunity to refocus at a time of economic strength on the challenges that lie ahead", says William M. Burns, Pharmaceuticals Division CEO. "New structures and flatter hierarchies will enable us to be more aligned and focused, take decisions faster, implement ideas more rapidly, and bring more new products through the pipeline".

Personnel changes The new model involves leadership changes in R&D. Jonathan Knowles, President of Global Research will focus on his role as Head of Group Research. In this role he will be in charge of coordinating research across Roche Pharmaceuticals, Roche Diagnostics, Chugai, Genentech and other partners. Lee Babiss, currently Research Site Head in Nutley, has been appointed to the position of Head of Roche Pharma Research. This newly created role will focus on leading and managing Research within Roche Pharma, including research sites in Basel, Nutley, Palo Alto, Penzberg and Shanghai. Eduard Holdener will, as previously announced, retire at the end of 2007. His role as Head of Global Pharmaceutical Development was taken over on 1 January 2007 by Jean-Jacques Garaud, who, like Lee Babiss, reports to William M. Burns and is also a member of the Pharmaceuticals Executive Committee. Until his retirement, Eduard Holdener will, as Chief Medical Officer, continue to have direct responsibility for Drug Safety and Quality Audit and for setting up the Development Centre in Shanghai.

Investment, innovation network and personalised medicine Roche's recent R&D investment has risen to 6 billion Swiss francs ($4.8bn) per annum, with research staff numbers exceeding 6500. Roche will increase its R&D investment yet again this year and expects a commensurate boost in the number of its R&D staff. It will continue to pursue its unique R&D network strategy which, together with Genentech and Chugai and numerous alliances worldwide, provides broad access to innovation. Cooperation between the Pharmaceuticals and Diagnostics Divisions in the area of personalised medicine will be further strengthened, thus consolidating the Roche Group's leading position in this area.

Roche pipeline highlights Roche's rich and promising pharmaceutical pipeline includes as of September 30, 2006, 61 new molecular entities and 54 additional indications in development addressing major unmet medical needs. The growth drivers in the near future are expected to come from the areas of oncology, autoimmune diseases and metabolic disorders.

Oncology Roche possesses one of the strongest oncology pipelines in the industry. With 32 projects in research, 41 in development * and numerous additional indications for products already marketed, Roche addresses all major tumour categories and offers cancer drugs for both early intervention and supportive care.

Inflammation The Roche Group has invested in a broad autoimmune disease portfolio and pipeline focused on clinically differentiated compounds (14 projects in research and 13 in development*). Two first-in-class molecules (MabThera/Rituxan, already on the market; Actemra, in phase III) with novel mechanisms of action provide benefits for patients responding inadequately to current therapeutic options, or for whom these therapies may offer an excellent first choice in the future.

Metabolism Also in the pipeline are numerous potential medicines for vascular and metabolic disorders (29 projects in research and 11 in development*), including treatments for diabetes which, together with Roche's broad Diabetes Care portfolio in Diagnostics, will contribute to the company's growth over the coming years.

* Status of September 30, 2006

For further pipeline information, see Roche's updated pipeline chart on 7th February 2007. Link: www.roche.com

About Roche Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. Roche employs roughly 70,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai.

All trademarks used or mentioned in this release are protected by law.

Roche Group Media Office Phone: +41 -61 688 8888 / e-mail: basel.mediaoffice@roche.com - Baschi Dürr - Daniel Piller (Head of Roche Group Media Office) - Katja Prowald (Head of R&D Communications) - Martina Rupp

F. Hoffmann-La Roche Ltd Corporate Communications Grenzacherstrasse 124 4070 Basel, Switzerland

Phone: +41 61 68 88888 Fax: +41 61 68 82775 mailto:basel.mediaoffice@roche.com www.roche.com

Press Release: Roche and Synosis Therapeutics Announce Partnership to Explore Potential of Five Compounds Targeting the CNS

Maureen Martino — Fri, 05 Jan 2007 11:53:10 -0500

Roche and Synosis Therapeutics Announce Partnership to Explore Potential of Five Compounds Targeting the Central Nervous System

BASEL, Switzerland and SAN FRANCISCO, CA, USA -- Roche and Synosis Therapeutics today announced a new partnership that could lead to the development of treatments for schizophrenia, cognitive disorders, Parkinson's, drug dependency and pain

The broad partnership centres on five drug candidates that Synosis will acquire from Roche, including four phase 1 molecules, which target the central nervous system (CNS). Roche had discontinued the development of these compounds in previous reprioritization processes. Under the terms of the deal, Synosis will be responsible for the clinical development and, in some cases, commercialisation of the drug candidates in multiple indications. Roche will retain the right to opt-in to two pre-selected programs. Financial terms of the deal were not disclosed.

"By partnering with Synosis, we're giving these potential medicines the best chance of success by creatively extending our innovation base in an important therapeutic area," said Peter Hug, Roche's Global Head of Pharma Partnering. "There is a real need for new treatments for CNS diseases, such as schizophrenia and Parkinson's, and we're excited by the potential of this partnership."

Dr Ian Massey, Chief Executive Officer of Synosis Therapeutics said: "Roche has a long and distinguished record in the field of CNS discovery. Our combined understanding of the possibilities of these programs in addition to Synosis' focus on translational medicine gives us the opportunity to explore their full therapeutic potential."

One of the founding investors Brad Bolzon, Managing Director of Versant Ventures, said:

"Unlike the traditional licensing model, this deal shows how venture capitalists and pharma can build partnerships based on a whole portfolio of promising clinical-stage drug candidates. This investment should unlock the potential value of these compounds in new indications."

Terms of the Agreement

Under the terms of the agreement, Synosis will assume responsibility for the clinical development of the five drug candidates. Roche retains the right to opt-in to potential products resulting from two of these programs on completion of agreed milestones. Synosis retains full commercial rights to three pre-selected programs and can bring these products to market either alone or with a partner. Financial terms were not disclosed.

About Synosis Therapeutics

Synosis Therapeutics is a privately-owned, drug development company, focused on developing new treatments for disorders of the central nervous system. Its leadership team has over 180 years of combined experience in drug development, including senior roles at Roche and Novartis. Synosis has offices in Basel, Switzerland, and is headquartered in South San Francisco, CA. The company was spun out of EuroVentures Inc., a wholly-owned incubator of Versant Ventures. Synosis Therapeutics has raised $32.5 million funding from Versant Ventures (Menlo Park, CA), Abingworth Management (London), 5AM Ventures (Menlo Park, CA) and Novo A/S (Copenhagen, Denmark). For more information, visit www.synosis.com

About Roche as a Partner

Roche is a valued partner to around 80 companies worldwide. Over the past two years, Roche has led the pharmaceutical industry in the number of clinical compound deals signed. In 2006, Roche entered into nine partnerships to jointly develop products for optimal patient benefit and value. Partnerships continue to strengthen Roche's positions in oncology, virology, transplantation, and primary care. Roche's partnering culture encourages innovation through a unique pairing of collaboration and autonomy.

About Roche

Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2005 sales by the Pharmaceuticals Division totalled 27.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.2 billion Swiss francs. Roche employs roughly 70,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Additional information about the Roche Group is available on the Internet (www.roche.com)

Press Release: BioAxone Therapeutic Licenses Phase II Spinal Cord Injury Drug Cethrin to Boston Life Sciences

Maureen Martino — Thu, 04 Jan 2007 12:07:47 -0500

BioAxone Therapeutic Licenses Phase II Spinal Cord Injury Drug Cethrin to Boston Life Sciences

MONTREAL, January 04, 2007 - BioAxone Therapeutic announced today that it has licensed its clinical phase II spinal cord injury drug Cethrin to Boston Life Sciences, Inc. . The worldwide, exclusive licensing agreement grants Boston Life Sciences the rights to develop and commercialize BioAxone's portfolio of proprietary recombinant fusion proteins, products, and associated patents to treat acute spinal cord injury (SCI) and other serious central nervous system disorders. The license provides for an up-front license fee of US$10 million payable in 2 installments (US$2.5 million paid on execution and US$7.5 million due on or before March 31, 2007), possible performance milestones of up to US$25 million and on-going royalties based on sales of Cethrin after approval. Detailed terms of the license were not disclosed.

In November 2006, interim results from Cethrin's open-label, clinical phase I/IIa North American dose escalation trial in SCI were published, indicating that a one-time application of Cethrin(R) onto the dura mater of the injured spinal cord is safe and well tolerated. The trial also has an efficacy component based on the American Spinal Injury Association's (ASIA) scale which is designed to assess sensory and motor function in patients. In this trial, 31% of patients, after six weeks, recovered some sensory and/or motor function below the level of their injury and converted from a complete injury to an incomplete injury. These functional benefits may be dose dependent.

"Boston Life Sciences' focus on axonal regeneration to restore sensory and motor function after severe nerve damage, along with their expertise in spinal cord injury, stroke and ocular injury, makes them an ideal licensing partner for BioAxone," said Dr. Frank Bobe, President and CEO of BioAxone. "Cethrin will be a core program for BLSI, thus assuring rapid clinical development and commercialization. Boston Life Sciences neuroregenerative programs are highly synergistic with BioAxone's technology. We are confident that we will see additional drug candidates evolve over time from this agreement."

"We are enthusiastic about having signed this licensing agreement with BioAxone," said Dr. Mark Pykett, President and COO of Boston Life Sciences. "The early clinical results from Cethrin's SCI trial are encouraging. They support pre-clinical studies in which the drug was found to be effective in facilitating axon regeneration following an acute injury to the CNS. If successfully developed, Cethrin could address a significant unmet medical need in acute spinal cord injury."

"During the next few months, BioAxone will work closely with Boston Life Sciences to ensure an efficient transfer of this technology," added Dr. Bobe. "We will jointly work with our stakeholders, in particular our clinical investigators who have been very committed and supportive through-out Cethrin's first clinical trial in acute spinal cord injury."

About Cethrin

Cethrin is a recombinant protein which promotes neuroregeneration in the central nervous system (CNS). It was engineered by BioAxone to effectively penetrate into CNS tissue, where it has been clearly shown to elicit the rescue and repair of damaged neurons in preclinical animal models. Cethrin is delivered in a single dose directly onto the dura mater of the spinal cord during decompression/stabilization surgery. Cethrin was granted Orphan Drug status by the U.S. Food and Drug Administration (FDA) in December 2005.

About BioAxone Therapeutic

BioAxone is a privately owned neuroscience company specializing in the development and commercialization of proprietary technologies that target Rho signaling. Established in April 2000 and headquartered in Montreal, Canada, BioAxone has demonstrated expertise in recombinant protein product development and has a focused small-molecule program.

Desjardins Securities Inc. acted as financial and strategic advisor to Bioaxone in this licensing transaction.

CONTACT: Dr. Frank Bobe, President and CEO, BioAxone Therapeutic Inc.,(514) 282-9990, www.bioaxone.com

FDA: Safety Concern Regarding Rituxan in New Patient Population

Maureen Martino — Tue, 19 Dec 2006 11:27:16 -0500

FDA Warns of Safety Concern Regarding Rituxan in New Patient Population

The Food and Drug Administration (FDA) is alerting health care professionals and patients treated with Rituxan (rituximab) to reports of an emerging risk of a serious side effect in patients receiving or who have used Rituxan. FDA recently learned that two patients who were treated with Rituxan for systemic lupus erythematosus (SLE) developed progressive multifocal leukoencephalopathy (PML), a fatal viral infection of the central nervous system. This side effect has been reported in patients as late as 12 months after their last dose of Rituxan.

SLE is not an approved indication for Rituxan. Rituxan is approved only for the treatment of patients with non-Hodgkin's lymphoma and patients with rheumatoid arthritis whose disease no longer responds to other common treatments.

"Rituxan is used in both approved and off-label settings, and therefore it is very important for prescribers as well as patients to be aware of these new reports of the risk of PML," said Dr. Steven Galson, director of FDA's Center for Drug Evaluation and Research. "Patients who are being treated or have been treated with Rituxan who experience any major changes in vision, balance, or coordination, or who experience confusion, should promptly call their doctor."

Rituxan, which has been marketed since 1997, acts on the body's immune system by decreasing certain types of white blood cells. This makes the drug effective in treating lymphoma and rheumatoid arthritis, but it also increases the body's susceptibility to infection. The Rituxan label was updated in February 2006 to include postmarketing reports of cases of serious viral illnesses, including PML, in patients with lymphoma who received Rituxan. There have been 23 confirmed cases of PML in patients with lymphoid malignancies either during or after completion of treatment with Rituxan. The majority of these patients also had received other drugs known to affect the immune system.

Additionally, cases of PML have occurred in patients who have not received Rituxan. Most reports have been in patients with a compromised immune system, either due to medical conditions (lymphoma or blood cancers, HIV infection and congenital immunodeficiency syndromes) or medical treatments (cancer chemotherapy and immunosuppressive medications in organ transplant recipients). There also have been literature reports of PML in patients with SLE who did not receive Rituxan, but had received other immunosuppressive drugs. Currently FDA is working with Genentech, the drug's sponsor, to add this recent information on PML to the drug label.

Health care professionals should report any serious adverse events possibly associated with the use of Rituxan to FDA's MedWatch Adverse Event Reporting program online [at www.fda.gov/MedWatch/report.htm], by phone [1-800-FDA-1088], or by returning the postage-paid FDA form 3500 [which may be downloaded from www.fda.gov/MedWatch/getforms.htm] by mail [to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or fax [1-800-FDA-0178].

Rituxan is manufactured by Genentech, Inc. of South San Francisco, Calif.

FDA: Safety Concern Regarding Rituxan in New Patient Population

Maureen Martino — Tue, 19 Dec 2006 11:27:16 -0500

FDA Warns of Safety Concern Regarding Rituxan in New Patient Population

Rituxan is manufactured by Genentech, Inc. of South San Francisco, Calif.

Press Release: PsychoGenics Announces Drug Discovery And Development Agreement With Eli Lilly

Maureen Martino — Tue, 19 Dec 2006 09:18:46 -0500

PsychoGenics Announces Drug Discovery And Development Agreement With Eli Lilly and Company

TARRYTOWN, N.Y., Dec 19 -- PsychoGenics Inc. today announced that it has entered into a drug discovery and development agreement with Eli Lilly and Company (NYSE: LLY - News). Per the agreement, Lilly will provide drug candidates that PsychoGenics will evaluate, using its proprietary drug discovery technologies, for the treatment of neuropsychiatric disorders.

The agreement provides either party the option to exclusively develop any drug candidate emerging from this collaboration, with the non-developing party receiving milestones and royalties commensurate with the stage of development.

Dr. Emer Leahy, President and CEO of PsychoGenics said, "We are delighted to enter into this agreement which expands our relationship with Lilly. We are confident, given our successes with other partners to date, that our proprietary and comprehensive approach may identify unexploited commercial potential for a variety of discontinued or de-prioritized Lilly compounds."

PsychoGenics' technologies combine its broad in vivo behavioral expertise together with recent developments in robotics, computer vision and bio/cheminformatics to evaluate drug candidates for potential utility across the spectrum of neuropsychiatric disease indications. Working in partnership with pharmaceutical and biotech companies, PsychoGenics has been instrumental in identifying therapeutic potential for discontinued compounds as well as early stage compounds including some with novel "first-in-class" mechanisms of action.

About PsychoGenics

PsychoGenics is a leader in preclinical behavioral neurobiology. The Company applies its behavioral expertise together with advances in robotics, computer vision and informatics to provide innovative solutions for central nervous system drug discovery. PsychoGenics works with pharmaceutical and biotechnology companies, academic institutions and not-for-profit research foundations to help discover treatments for such major neurological and psychiatric disorders as: ALS, anxiety, cognitive impairment, depression, Huntington's Disease, psychosis/schizophrenia, and SMA. The Company's in house discovery efforts have focused on psychiatric indications. For more information on PsychoGenics Inc. visit http://www.psychogenics.com

Source: PsychoGenics Inc.

NeoPharm investors exact revenge on trial failure

Sun, 10 Dec 2006 19:01:37 -0500

NeoPharm was also dealing with the ugly aftermath of its own trial failure this morning. Its stock plunged more than 70 percent after the company announced that its experimental therapy for malignant tumors of the central nervous system had failed a Phase III trial, failing to prove more effective than an existing therapy. Officials will also ponder the fate of cintredekin besudotox with regulators and researchers.

"Top-line data suggests that cintredekin besudotox, while comparable, was not statistically superior to Gliadel," said Guillermo Herrera, Neopharm's president and CEO. "We will continue to work with our Scientific Advisory Board and the FDA to determine the best path forward."

- see this press release on the trial
- here's the AP report on the data

Related Articles:
Analysts turn bullish on Neopharm's IL-13. Report
NeoPharm announces job cuts in restructuring. Report

Press Release: Memory Pharmaceuticals Announces Release of Clinical Hold on MEM 3454

Maureen Martino — Sun, 10 Dec 2006 11:43:22 -0500

Memory Pharmaceuticals Announces Release of Clinical Hold on MEM 3454

MONTVALE, N.J., Dec. 11 -- Memory Pharmaceuticals Corp. today announced that the U.S. Food and Drug Administration (FDA) has completed its review of the investigational new drug application (IND) for MEM 3454 and has informed the Company that the clinical hold on the development of this drug candidate has been released. The Company now plans to commence its previously-announced Phase 2a clinical trial for MEM 3454 in Alzheimer's disease during the first quarter of 2007.

"Memory has worked diligently with the FDA since this trial was placed on clinical hold in October, and we are pleased that we will now be able to move forward with the proof-of-concept trial for this important drug candidate," stated Jim Sulat, President and Chief Executive Officer of Memory Pharmaceuticals. "Given the safety and pharmacokinetic results of the Phase 1 trial for MEM 3454 and the positive cognitive data generated in that trial, we believe that MEM 3454 may offer a new approach for the treatment of debilitating central nervous system disorders."

About the Company

Memory Pharmaceuticals Corp., a biopharmaceutical company, is focused on developing innovative drugs for the treatment of debilitating CNS disorders such as Alzheimer's disease, schizophrenia, depression and bipolar disorder. For additional information, please visit our website at http://www.memorypharma.com.

Safe Harbor Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or Memory Pharmaceuticals' prospects, future financial position, future revenues and projected costs should be considered forward-looking. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, including the risks and uncertainties associated with: obtaining additional financing to support Memory Pharmaceuticals' R&D and clinical activities and operations; conducting preclinical and clinical trials of Memory Pharmaceuticals' drug candidates that demonstrate these candidates' safety and effectiveness; obtaining regulatory approvals to conduct clinical trials and to commercialize Memory Pharmaceuticals' drug candidates; Memory Pharmaceuticals' ability to enter into and maintain collaborations with third parties for its drug development programs; Memory Pharmaceuticals' dependence on its collaborations and its license relationship with Bayer; achieving milestones under Memory Pharmaceuticals' collaborations; Memory Pharmaceuticals' dependence on third- party preclinical or clinical research organizations, manufacturers and consultants; and protecting the intellectual property developed by or licensed to Memory Pharmaceuticals. These and other risks are described in greater detail in Memory Pharmaceuticals' filings with the Securities and Exchange Commission. Memory Pharmaceuticals may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. Memory Pharmaceuticals disclaims any intent or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.

Source: Memory Pharmaceuticals Corp.

PerkinElmer acquires Evotec Tech in cash buyout

Thu, 30 Nov 2006 19:01:37 -0500

The UK's PerkinElmer will acquire Evotec AG's Evotec Technologies subsidiary for €23 million in cash. The subsidiary provides systems for confocal imaging, cell handling, ultra-high throughput screening as well as image capture and cellular analysis software. PerkinElmer says it can take the technology op to a new level. For Evotec AG CEO Joern Aldag, the deal marks his company's central focus on developing new therapies.

"This transaction is another milestone in our strategy to focus Evotec on its drug discovery and development business," said Aldag. "Together with the sale of certain technology assets of Evotec Technologies to Olympus earlier in the year, the combined divestments value Evotec Technologies at approximately EUR 30 million. The cash proceeds will provide us with additional flexibility to progress and expand our central nervous system pipeline."

- read the release on the deal

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Press Release: PerkinElmer to Acquire Evotec Technologies

Maureen Martino — Thu, 30 Nov 2006 12:21:23 -0500

PerkinElmer to Acquire Evotec Technologies
Focuses Evotec on Core Business Drug Discovery and Development

HAMBURG, Germany & OXFORD, England--(BUSINESS WIRE)--Evotec AG (Frankfurt Stock Exchange: EVT, TecDAX 30) today announced that PerkinElmer Inc. (NYSE: PKI) signed a definitive agreement to acquire Evotec Technologies GmbH in a cash transaction valued at approximately EUR 23 million. Evotec Technologies is a majority owned subsidiary of Evotec AG, which provides systems for confocal imaging, cell handling, ultra-High Throughput Screening (uHTS) as well as image capture and cellular analysis software. The transaction is subject to regulatory approvals and other customary closing conditions and closing is expected to occur late December 2006 or early 2007. Evotec Technologies will be deconsolidated from Evotec’s financial statements as of 01.01.2007.

“With its sophisticated product portfolio and its strong customer base Evotec Technologies has grown into a position of strength. To bring the company to the next level of its development, a partnership with a global provider of instrumentation and consumables became paramount. We believe that PerkinElmer is best positioned to leverage Evotec Technologies’ full potential,” said Joern Aldag, CEO of Evotec AG. “This transaction is another milestone in our strategy to focus Evotec on its drug discovery and development business. Together with the sale of certain technology assets of Evotec Technologies to Olympus earlier in the year, the combined divestments value Evotec Technologies at approximately EUR 30 million. The cash proceeds will provide us with additional flexibility to progress and expand our Central Nervous System pipeline.”

“Over the past years we have positioned Evotec Technologies to become the premium international supplier of tools and technologies for modern cellular research. Our cutting edge cell analysis, automation and software solutions are the foundation of our leading position in this market segment,” commented Prof Carsten Claussen, CEO of Evotec Technologies GmbH. “This is the time to exploit our potential as part of a larger entity with a significantly broader sales force, portfolio strategy and R&D resources. We look forward to becoming the Center for Cellular Sciences in Hamburg within the PerkinElmer group.”

Evotec Technologies’ high-performance HCS instruments and image analysis software help pharmaceutical, biotechnology and academic researchers automate cell screening and analysis for drug discovery. Included in the company’s portfolio is the Opera™ HCS platform, a premier tool for high content analysis that combines the precision of confocal microscopy with the throughput required for primary and secondary screening. This technology is intended to enable researchers to move drug candidates more quickly and confidently through preclinical and clinical phases.

“Our customers today require unique, flexible tools and platforms that produce better quality and biologically relevant data for mapping cellular events to new discoveries,” said Gregory L. Summe, Chairman and Chief Executive Officer, PerkinElmer, Inc. “Evotec Technologies’ strong product portfolio - combined with PerkinElmer’s global distribution capabilities, service and support – will help our customers speed target validation and lead optimisation along the drug discovery value chain.”

Conference Call

Evotec will host a conference call tomorrow at 11.00 a.m. CET (10.00 a.m. GMT/5.00 a.m. US time East Coast). Joern Aldag, President & CEO and Dr Dirk Ehlers, CFO will lead the call.

Conference call numbers:
Europe: +49.(0)69.5007 1307 (Germany) +44.(0)20.7806 1955 (UK) US: +1.718.354 1388

A replay of the conference call will be available for 24 hours and can be accessed in Europe by dialing +49.(0)69.22222 0418 (Germany) or +44.(0)20.7806 1970 (UK) and in the US by +1.718.354 1112. The access code is 4384847#.

Notes to the editor

About Evotec Technologies

Evotec Technologies GmbH is the world’s leading provider of confocal detection devices (Opera™, Clarina™, Insight™ Cell), cell handling devices (CytoClone™, Cytocon™) and ultra-High-Throughput Screening (uHTS) systems (EVOscreen®, plate::explorer™). The Company’s product portfolio is focused on high-end technologies for automated cell biology. Evotec Technologies employs 85 people, primarily at its main site in Hamburg, Germany. In 2005, the company generated sales of EUR 17.0 million.

www.evotec-technologies.com

About PerkinElmer

PerkinElmer, Inc. is a global technology leader driving growth and innovation in Health Sciences and Photonics markets to improve the quality of life. The Company reported revenues of $1.5 billion in 2005, has 8,000 employees serving customers in more than 125 countries, and is a component of the S&P 500 Index.

www.perkinelmer.com

About Evotec AG

Evotec is a leader in the discovery and development of novel small molecule drugs. Both through its own discovery programmes and through contract research partnerships, the Company is generating the highest quality research results for its partners in the pharmaceutical and biotechnology industries. In proprietary projects, Evotec specialises in finding new treatments for diseases of the Central Nervous System.

In 2005, Evotec generated sales of EUR 80 million with 600 employees located in Hamburg, Germany and near Oxford and in Glasgow, UK.

Press Release: Orexigen Therapeutics Completes $30 Million Series C Financing

Maureen Martino — Tue, 21 Nov 2006 11:52:46 -0500

OREXIGEN(TM) Therapeutics Completes $30 Million Series C Financing

SAN DIEGO, Nov. 22 /PRNewswire/ -- OREXIGEN(TM) Therapeutics, Inc., a privately held clinical-stage neuroscience company developing novel strategic approaches to the treatment of obesity, today announced the completion of a $30 million Series C private equity financing. Proceeds from the Series C financing will be used to advance OREXIGEN's clinical programs for its two lead drug candidates for the treatment of obesity and for general corporate purposes.

Existing investors participated in the financing, along with new investors MPM BioEquities and Wasatch Advisors.

About OREXIGEN Therapeutics

OREXIGEN(TM) Therapeutics, Inc. is a privately held clinical-stage neuroscience company in San Diego, California developing novel strategic approaches to the treatment of obesity. OREXIGEN leverages its proprietary science to design and screen drugs and drug combinations that work together in the central nervous system to enhance satiety, diminish appetite, improve energy expenditure and minimize the body's efforts to compensate for weight loss. OREXIGEN has two lead drug candidates in clinical trials, Contrave(TM) (phase II/III) and Excalia(TM) (phase IIb), along with a pipeline of earlier stage drug combinations now being tested. Each is designed to act on a specific group of neurons in the central nervous system with the goal of achieving appetite suppression and sustained weight loss. By targeting different groups of neurons OREXIGEN is working to develop compounds that each can achieve a different weight loss profile, providing rapid weight loss where required (Excalia) or emphasizing steady, sustainable weight loss where preferred (Contrave). Further information about the company can be found at www.orexigen.com.

OREXIGEN cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. These forward-looking statements include statements regarding the efficacy and safety of OREXIGEN's product candidates and the potential to obtain regulatory approval for, and effectively treat obesity with, any of these product candidates. The inclusion of forward-looking statements should not be regarded as a representation by OREXIGEN that any of its plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in OREXIGEN's business, including, without limitation: the scope and validity of patent protection for OREXIGEN's product candidates; the progress and timing of OREXIGEN's clinical trials, and the potential for OREXIGEN's product candidates to receive regulatory approval on a timely basis or at all; the market potential for obesity, and OREXIGEN's ability to compete in the obesity market. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and OREXIGEN undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof.

Press Release: Vanda Pharmaceuticals Posts Positive Phase 3 Data

Maureen Martino — Tue, 14 Nov 2006 10:33:46 -0500

Vanda Pharmaceuticals' VEC-162 Demonstrates Positive Results in a Phase III Transient Insomnia Clinical Trial

VEC-162 Demonstrates Statistically Significant Improvement vs. Placebo in Measures of Sleep Onset and Sleep Maintenance
Validates Unique Mechanism of Action and Positioning for Unmet Medical Needs

ROCKVILLE, Md., Nov. 15 /PRNewswire-FirstCall/ -- Vanda Pharmaceuticals Inc. (Nasdaq: VNDA - News), a biopharmaceutical company focused on the development and commercialization of clinical-stage product candidates for central nervous system disorders, today announced positive top-line results from the company's Phase III clinical trial evaluating VEC-162, a balanced melatonin receptor agonist, in transient insomnia. VEC-162 demonstrated statistically significant improvements at all three tested doses compared to placebo in the primary endpoint of the trial, Latency to Persistent Sleep (LPS), a measure of sleep onset. VEC-162 also produced statistically significant improvements relative to placebo in Latency to Non-Awake (LNA), another measure of sleep onset, Wake After Sleep Onset (WASO), a measure of sleep maintenance, and Total Sleep Time (TST). VEC-162 was also demonstrated to be safe and well-tolerated.
The Phase III trial was a randomized, double-blind, placebo-controlled, multi-center study that enrolled 412 adults in a sleep laboratory setting using a phase-advance, first-night assessment model of induced transient insomnia. The trial examined VEC-162 dosed 30 minutes before bedtime at 20, 50 and 100 mg versus placebo.

VEC-162 achieved statistically significant results in multiple endpoints captured using polysomnography (PSG) including:

* Latency to Persistent Sleep (LPS): Improvement compared with placebo of 21.5, 26.3, and 22.8 minutes at 20, 50, and 100 mg respectively.

* Latency to Non-Awake (LNA): Improvement compared with placebo of 11.1), 14.3, and 12.3 minutes at 20, 50, and 100 mg respectively.

* Wake After Sleep Onset (WASO): Improvement compared with placebo of 24.2, 33.7, and 17.5 minutes at 20, 50, and 100 mg respectively.

* Total Sleep Time (TST): Improvement compared with placebo of 33.7, 47.9 and 29.6 minutes at 20, 50, and 100mg respectively.

The trial also demonstrated that VEC-162 was well-tolerated.
"We are extremely pleased with the positive results of this Phase III clinical trial," stated Paolo Baroldi, M.D., Ph.D., Senior Vice President and Chief Medical Officer of Vanda. "This study demonstrates VEC-162's ability to induce and maintain sleep. Also because VEC-162 is a balanced melatonin receptor agonist that works through the natural sleep/wake cycle, it appears to lack the side effects associated with hypnotics and sedatives and should not be scheduled as a controlled substance."

Mihael Polymeropoulos, M.D., President and CEO of Vanda, added that "VEC- 162 may be an effective new treatment for sleep disorders in general, and also may be able to treat an important subset of sleep disorder patients for whom there is currently no available, effective drug treatment. These patients have Circadian Rhythm Sleep Disorders, or CRSD. CRSDs are sleep disorders arising from a misalignment of the circadian rhythm, where a person's internal sleep/wake cycle does not match his or her desired sleep time. Examples include shift worker sleep disorder, delayed sleep phase syndrome, and jet lag. We believe VEC-162 is the only compound with a proven ability to modify the sleep/wake cycle and could be an important treatment for the large number of CRSD patients."

About Insomnia and Circadian Rhythm Sleep Disorders (CRSD)

Approximately 70 million American adults experience insomnia of all types. Circadian Rhythm Sleep Disorders (CRSD), one type of insomnia, affect millions of Americans in a number of forms. Shift Worker Sleep Disorder is a CRSD affecting the 14% of Americans who are shift workers. According to the National Sleep Foundation (NSF) shift workers are more likely to suffer from sleep disorders than people who work during normal business hours. Also according to the NSF, another CRSD, Delayed Sleep Phase Syndrome, is thought to affect 5-10% of patients in sleep disorder clinics and to account for 40% of disorders involving sleep-wake schedules.

CONFERENCE CALL

The company has scheduled a conference call for today, Wednesday, November 15, 2006 at 9:00 AM ET. During the call, Mihael Polymeropoulos, M.D., President and CEO will discuss the results of this Phase III trial. Investors can call 1-866-770-7129 (domestic) and 1-617-213-8067 (international) prior to the 9:00 AM start time and ask for the Vanda Pharmaceuticals conference call hosted by Dr. Polymeropoulos. A replay of the call will be available on Wednesday, November 15, 2006, beginning at 10:30 AM ET and will be accessible until Wednesday, November 22, 2006, at 5:00 PM ET. The replay call-in number is 1-888-286-8010 for domestic callers and 1-617-801-6888 for international callers. The access number is 29965398.

The conference call will be broadcast simultaneously on the company's Web site, http://www.vandapharma.com. Investors should click on the Investor Relations tab and are advised to go to the Web site at least 15 minutes early to register, download, and install any necessary audio software. The call will also be archived on the Vanda Web site for a period of 30 days, through December 15, 2006.

NOTE REGARDING FORWARD-LOOKING STATEMENTS

This release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding Vanda's plans for its product candidates. Words such as, but not limited to, "look forward to," "believe," "expect," "anticipate," "estimate," "intend," "plan," "targets," "likely," "will," "would," "should," and "could," and similar expressions or words, identify forward-looking statements. Such forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Vanda is at an early stage of development and may not ever have any products that generate significant revenue. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, a failure of Vanda's product candidates to be demonstrably safe and effective, a failure to obtain regulatory approval for the company's products or to comply with ongoing regulatory requirements, a lack of acceptance of Vanda's product candidates in the marketplace, a failure of the company to become or remain profitable, Vanda's inability to obtain the capital necessary to fund its research and development activities, a loss of any of the company's key scientists or management personnel, and other factors that are described in the "Risk Factors" section of Vanda's report on Form 10-Q for its third quarter ended September 30, 2006. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. The information in this release is provided only as of the date of this release, and Vanda undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

ABOUT VANDA PHARMACEUTICALS INC.:

Vanda Pharmaceuticals Inc. is a biopharmaceutical company focused on the development and commercialization of clinical-stage product candidates for central nervous system disorders. The company has three product candidates in clinical development. Vanda's lead product candidate, iloperidone, is a compound for the treatment of schizophrenia and bipolar disorder and is in Phase III for schizophrenia. Vanda's second product candidate, VEC-162, is a compound for the treatment of sleep and mood disorders which is currently in Phase III for insomnia. Vanda's third product candidate, VSF-173, is a compound for the treatment of excessive sleepiness and is ready for a Phase II clinical trial. For more on Vanda Pharmaceuticals Inc., please visit http://www.vandapharma.com.

Source: Vanda Pharmaceuticals Inc.

Addex lands $32M in third round

Mon, 18 Sep 2006 20:01:37 -0400

Addex Pharmaceuticals, a developer of drugs for Central Nervous System (CNS) disorders, has landed $32 million in its third round of venture capital. GSK's venture capital division SR One led the round. Additional investors included the Roche Venture Fund, Sofinnova Partners, Index Ventures, TVM Capital, PolyTechnos Venture-Partners, Bio*One Capital, Renaissance PME and Varuma. This brings the company's venture capital total to $81 million since 2002. The funding will be used to develop Addex's clinical and pre-clinical drug candidates, including ADX10059, which is currently in Phase II testing for acute migraine and gastro oesophageal reflux disease (GERD).

- see the press release from Addex's Web site