schizophrenia

Acadia shares plunge on mid-stage trial failure

John Carroll — Mon, 16 Jun 2008 09:26:07 -0400

Shares of Acadia Pharmaceuticals went into free fall this morning after the company announced that one of its schizophrenia drug candidates failed a mid-stage trial. Researchers said that ACP-104 was no better than a placebo in relieving symptoms of schizophrenia. And the company said that they would probably shutter the development program as a result of the data.

That news sent Acadia's stock into a nose dive, with shares losing 56 percent of their value this morning. Acadia does have another schizophrenia drug--pimavanserin--in mid-stage development.

"We clearly are disappointed in the results of this study," said Uli Hacksell, Ph.D., the CEO of Acadia. "While we will thoroughly analyze the data to understand the outcome, we currently do not anticipate conducting further studies with ACP-104."

- check out the press release
- read the AP report

Roche expands Memory pact

Fri, 02 May 2008 06:59:55 -0400

Roche has exercised its option to further develop and commercialize Memory Pharmaceuticals' drug candidate, MEM 3454, for various neurological and psychiatric disorders. Memory gets a $6 million milestone payment and will be eligible for a $17 million once an ongoing Phase IIa study in cognitive impairment associated with schizophrenia (CIAS) is completed. Back in November, Memory Pharmaceuticals announced a positive Phase II proof-of-concept trial of MEM 3454 in 80 patients with Alzheimer's disease.

"We are excited that Roche shares our enthusiasm for MEM 3454 and its potential to address the cognitive deficits associated with debilitating CNS disorders," stated Vaughn M. Kailian, Memory's CEO. "We have aggressively advanced MEM 3454 through early-stage clinical trials, including a positive Phase IIa trial in Alzheimer's disease. We believe that Roche's continued commitment to the program, together with its expertise in later-stage clinical development and commercialization, will provide the support and capabilities to realize the full potential of this compound."

- check out this release

Glutamate a big target for drug developers

Mon, 25 Feb 2008 06:59:56 -0500

The New York Times' Alex Berenson looks at the wave of new research programs focused on the neurotransmitter glutamate as a therapy for schizophrenia. Eli Lilly's Darryle D. Schoepp recognized its potential in the fall of 2006, and other drug discoverers weren't far behind as a number of developers jumped into the field. All approved therapies for schizophrenia target dopamine, and the glutamate connection opened up a host of possibilities for depression, Alzheimer's and other indications as well.

"I don't think people appreciate how much money, time and good technical research goes into what we do," Schoepp told the Times. "Sometimes, people think the idea is the thing. I think the idea can be the easy part."

- read the article from The New York Times

Related Articles:
Potential new drug found for schizophrenia. Report
Addex is talking deals as interest in a new class of drugs. Profile

Pfizer lands schizophrenia drug in $22M deal

Mon, 07 Jan 2008 06:59:57 -0500

Japan's Taisho has granted all commercial rights to its preclinical schizophrenia drug outside of Japan to Pfizer for $22 million up front. TS-032 is an mGluR agonist, which promises to influence the transmission of substances in the brain that is associated with schizophrenia. Taisho is an experienced player in the psychiatric drugs market. The Japanese company also stands to gain unspecified milestone payments for the drug.

- see this release
- read the AP report

Related Articles:
Lilly bows out of diabetes deal with Taisho. Report
New therapy found for schizophrenia. Report

Addex gains $702M on Merck deal

Thu, 03 Jan 2008 06:59:58 -0500

Addex Pharmaceuticals was focusing on the positive this morning when it touted a $702 million pact with Merck for an experimental schizophrenia drug candidate. Merck is paying $22 million up front and up to $455 million more for regulatory, sales and development milestones for ADX63365. The deal also outlines up to $225 million in milestone products for two indications involving a second product.

Separately, Addex announced that ADX10059 had failed a Phase IIa trial for acute anticipatory anxiety in patients with dental anxiety. But Addex says the drug still has potential for treating other anxieties. On balance, investors and analysts saw more good than bad news in the twin announcements. Addex shares rose slightly.

"Through this second collaboration with Addex we have now gained access to a promising drug candidate targeting this receptor that potentially allows us to address an area of high medical importance where current therapies are clearly inadequate," said Merck's Darryle D. Schoepp.

- see this release on the Merck deal
- and here is the release on the trial data
- check out the report from Dow Jones

Related Articles:
Merck partners with Addex. Report
Addex pockets $111M in successful IPO. Report

ALSO NOTED: GPC Biotech's CFO resigns; Abbott Labs cuts 1,200 jobs; and much more...

Wed, 05 Dec 2007 06:59:50 -0500

> GPC Biotech's CFO Mirko Scherer has resigned; he will be replaced by Torsten Hombeck, Ph.D. Release

> A new entrant into the layoff club is Abbott Laboratories, which says it's cutting 1,200 jobs in Ireland and California. Report

> Immtech Pharmaceuticals will allow BioAlliance Pharma to commercialize Immtech's oral drug, pafuramidine maleate, in Europe for the treatment of pneumocystis pneumonia in AIDS patients and for the treatment of Human African trypanosomiasis, also known as African sleeping sickness. Release

> Lexicon Pharmaceuticals has begun dosing in a Phase IIa trial of LX6171, an oral drug candidate for the treatment of cognitive impairment associated with disorders such as Alzheimer's disease, schizophrenia, and vascular dementia. Report

> Adventrx Pharmaceuticals has completed patient enrollment in its Phase II trial of ANX-510, or CoFactor, for the treatment of advanced breast cancer. Report

> Preempt away. That's what the Bush Administration told the Supreme Court yesterday, supporting Medtronic's contention that its FDA-approved products shouldn't be subject to liability claims in state court. Report

> Scientists at Johns Hopkins were able to repair damaged skulls by transplanting human embryonic stem cells directly to the site of massive injuries. Report

> A team of scientists in the UK have designed a genetic tool that can disable genes equipped with antibiotic resistance, an approach that could scuttle superbugs like MRSA. Report

> Stimulating an "exercise" gene has a profound therapeutic effect on mice, raising the likelihood that a new drug that can trigger the same effect in humans, could work as a blockbuster antidepressant. Report

> The FDA warned doctors that desmopressin, a drug used to control bed-wetting, can cause some children to have potentially fatal seizures. Report

> Are drug makers responsible for a hospital's medical error? That's what actor Dennis Quaid and his wife are alleging in a lawsuit over the blood thinner given to their newborn twins last month. Report

And Finally... Honey may be an effective and safe alternative than over the counter children's cough medicines, according to a Penn State College of Medicine study. Release

ALSO NOTED: Sucampo Pharma names new CEO; Genetic tests are going DTC at a fast pace; Panel: Give FDA power to recall; and much

Tue, 06 Nov 2007 06:59:50 -0500

> Teva and the Technion Israel Institute of Technology are exploring a pact to develop stem cell lines for research work. Report

> Chutes & Ladders: Sucampo Pharma has named Kunihiko Soneoka as representative director, president and CEO. Release

> Predictive gene-based tests are going DTC, and a number of experts worry that it's all happening way too fast. Article

> A presidential panel is set to recommend giving the agency the authority to recall products all by its lonesome. Report

> The northward migration of drug buyers is slackening, according to pharmaceuticals datameister IMS Health. In 2006 U.S. customers only spent $211 on meds from Canadian pharmacies, compared with $420 million in 2005. Report

> Better late than never, Bristol-Myers Squibb might say. In a move that's sure to incite debate, the FDA says it will allow BMS to market its schizophrenia med Abilify for use in adolescents. Report

> Can poor countries get the meds they need for their people only by circumventing patents? That's the debate this week at a WHO confab aimed at supplying the developing world with the drugs it needs. Report

> A report in the Journal of Clinical Investigation sheds new light on the role of WNK kinases in regulating blood pressure, which in likely to trigger research into new therapies for the very common, lethal disease. Report

> What do Tokyo teenagers falling from buildings have in common with Roche? Possibly Tamiflu. Report

And Finally… A novel vaccine developed at The Scripps Research Institute at La Jolla may offer a new way to block infections without sparking bacterial resistance. Report

Memory's Alzheimer's drug aces Phase II

Fri, 02 Nov 2007 07:59:55 -0400

Memory Pharmaceuticals has announced a positive Phase II roof-of-concept trial of MEM 3454 in 80 patients with Alzheimer's disease over an eight week treatment period. The primary endpoint of the trial was the change from baseline in the Quality of Episodic Secondary Memory (QESM) factor score of the Cognitive Drug Research (CDR) battery. This is good news for Memory, which announced in mid-October that another drug, MEM 1003, failed a Phase IIa study.

"This data is consistent with our preclinical and Phase 1 results and reinforces our belief that MEM 3454 warrants continued development. We look forward to commencing our Phase IIa trial of MEM 3454 in cognitive impairment associated with schizophrenia in the near term."

- check out this press release for more

Related Articles:
Memory's Alzheimer's drug flunks Phase II. Report
Memory shares plunge as lead drug fails trial. Report
Big pharma sees big payback for Alzheimer's research. Report
Study shows that Alzheimer's drugs don't work. Report

Schizophrenia drug gets mixed results in IIb

Tue, 16 Oct 2007 06:59:56 -0400

Forest Laboratories and Hungary's Gedeon Richter says that high doses of its antipsychotic drug failed to demonstrate a statistically significant response in a Phase IIb trial, but low doses of RGH-188 reflected "nominally" significant results. Research will continue to determine if the therapy can work as a treatment for schizophrenia. A full set of data will be released in a few weeks, when analysts can get a better idea of what "nominally statistically significant" means.

- see the release for more information

Related Articles:
New schizophrenia drugs no better than generic. Report
Lilly's schizophrenia drug may offer breakthrough. Report
Forest Labs dumps failed stroke drug program. Report
Mice engineer to be schizophrenic. Report

Read more on: Forest Labs | Schizophrenia

ALSO NOTED: Novartis teams up with MIT; EMEA approves Galvus; and much more...

Fri, 28 Sep 2007 06:59:50 -0400

> Novartis is teaming up with MIT to develop new ways to manufacture drugs. The company will give the university $65 million over 10 years to create a new research program. Report

> Galvus, a once-daily oral treatment for type 2 diabetes, has been approved by the EMEA. Release

> Celera has earned a clinical milestone payment of $2 million from Merck. The payment was triggered by Merck's advancement of odanacatib into a Phase III clinical trial as a potential treatment for osteoporosis. Release

> Scientists at the Institute for Neurodegenerative Disorders report that they have identified a drug that could potentially treat the cognitive disorders associated with schizophrenia. Report

> A new study concludes that two enzymes--SIRT3 and SIRT4--play a key role in mitochondria, regulating the aging process. Report

And Finally... Researchers at Texas A&M University are participating in developing a medicine that is worth sneezing about: a treatment for influenza that forms a jelly when sprayed into the nose. Release

Pfizer's future rests with biotech

Maureen Martino — Thu, 13 Sep 2007 11:00:07 -0400

At this week’s Bear Stearns Healthcare Conference, Pfizer discussed its plans for the future with analysts. As we all know, Pfizer is facing a major loss of sales when its best-selling drug Lipitor goes off patent in 2010. This wasn’t a major cause for concern until January, when Pfizer abandoned development of Torcetrapib due to concerns about mortality and cardiovascular events. Torcetrapib was slated to replace Lipitor, and the stunning loss of the progam left a gaping hole in Pfizer’s pipeline. In addition to concerns about Lipitor, both Viagra and Geodon, a schizophrenia therapy, will be faced with generic competitors by 2014. All told, Pfizer has to find a way to replace an annual $19 billion in sales when these drugs go off patent.

So how is Pfizer planning to deal with this loss? Company officials told analysts that Pfizer would increase its focus on biologics, which are much more difficult to make generic copies of. Lawmakers and healthcare professionals both here and abroad have embraced generic pharmaceuticals, which are relatively easy for generic drugmakers to produce. But Congress and the FDA have been slow to greenlight a faster approval process for generic biologics (on the other hand, the EMEA has had a regulatory pathway in place for almost three years). Pfizer has already announced a plan to invest $10 million a year for the next five years to help start-up biotechs in San Diego. Expect to see Pfizer snapping up biologics from smaller drug developers and investing more money in biotech companies in the months and years to come.

- read the Motley Fool article for more

Related Articles:
Pfizer goes public with R&D pipeline. Report
Troubled Pfizer blueprints biotech venture effort. Report
Waiting game continues for biogenerics. Report
Democrats to push for generic biotech drugs. Report
Pfizer halts Torcetrapib development. Report
Wal-Mart expands $4 drug program, Target follows. Report
Biotech sees big money from corporate players. Report

Lilly's schizophrenia drug may offer breakthrough

Tue, 04 Sep 2007 06:59:58 -0400

Eli Lilly has revealed that a clinical trial involving some 200 volunteers has demonstrated the effectiveness of its experimental therapy against schizophrenia. The therapy is being heralded as a potential breakthrough in the field which would steer clear of many of the harsh side effects associated with existing schizophrenia drugs. Researchers also caution, though, that work on LY2140023 is still at an early stage. Nevertheless, analysts were awed by the potential of a new lead therapy in the field. Schizophrenia drugs took in $12 billion in the U.S. last year--$18 billion worldwide.

- check out the release
- read the report from MarketWatch

Related Articles:
Researchers: New schizophrenia drugs little better than the old. Report
Lilly agrees to $690M drug settlement. Report

Cortex gets green light to resume Alzheimer's trials

Tue, 17 Jul 2007 06:59:57 -0400

Cortex Pharmaceuticals says it will resume a study of its lead drug for Alzheimer's after getting a green light from the FDA. The agency put trials of CX717 on hold last year after it voiced concerns regarding animal data. The drug is designed to strengthen the brain signals of patients and is also being studied for narcolepsy, ADHD and schizophrenia. Researchers say they will soon approach the FDA to gain approval for a Phase IIb trial of CX717 for ADHD.

- see the release
- check out the AP report on the trial

Related Articles:
FDA hold lifted on Cortex drug. Report
Cortex shares plunge on CX717 failure. Report
Cortex names Varney new COO. Report

Press Release: Wyeth and Solvay Enter Into an Additional Neuroscience Collaboration

Maureen Martino — Thu, 11 Jan 2007 13:44:21 -0500

Wyeth and Solvay Enter Into an Additional Neuroscience Collaboration

MADISON, N.J., Jan. 11 - Wyeth Pharmaceuticals, a division of Wyeth and Solvay Pharmaceutical B.V. announced today that they have entered into a new neuroscience discovery, co-development, and co-commercialization agreement.

As announced in April 2004, Wyeth and Solvay previously entered into co-development and co-commercialization agreements for bifeprunox and other neuroscience compounds. This collaboration has already resulted in a New Drug Application submitted on October 11, 2006 to the U.S. Food and Drug Administration for bifeprunox for the treatment of patients with schizophrenia. Development continues on two other clinical stage neuroscience projects SLV-313 and SLV-314, which were part of the 2004 agreements.

Under the new agreement, the parties will collaborate in a joint discovery effort targeting the identification of small molecules as potential anti-psychotic medications. Any compounds discovered as part of the research collaboration will be jointly co-owned and patented by Wyeth and Solvay as well as co-developed and co-commercialized by the two companies.

"Pooling the experiences and know-how of Solvay and Wyeth will enhance the probability for the discovery of a number of novel pre-development neuroscience candidates," says Menelas Pangalos, Ph.D., Vice President, Neuroscience Discovery, Wyeth Research.

Each party is initially contributing several compounds to the collaboration for use in the joint discovery program, and thereafter the parties will contribute equal resources to the discovery effort.

There were no signing fees or milestone payments associated with the agreement.

Current Antipsychotic Treatments

All currently marketed efficacious antipsychotics used in the treatment of patients with schizophrenia and bipolar disorders target dopamine D2 receptors. The first generation typical antipsychotics, as well as second-generation atypical antipsychotics, are antagonists at dopamine D2 receptors. The third generation antipsychotics, such as bifeprunox, are partial agonists at dopamine D2 receptors. The potential advantage of a partial dopamine agonist is that a patient's symptoms can be stabilized without metabolic side effects associated with many current therapies.

About Wyeth Pharmaceuticals

Wyeth Pharmaceuticals has leading products in the areas of women's health care, cardiovascular disease, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products. Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing, and marketing of pharmaceuticals, vaccines, biotechnology products and non-prescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.

The statements in this press release that are not historical facts are forward-looking statements based on current expectations of future events and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include risks associated with the inherent uncertainty of the timing and success of product research, development and commercialization (including with respect to our pipeline products), drug pricing and payment for our products by government and third party-payors, manufacturing, data generated on the safety and efficacy of our products, economic conditions including interest and currency exchange rate fluctuations, changes in generally accepted accounting principles, the impact of competitive or generic products, trade buying patterns, global business operations, product liability and other types of litigation, the impact of legislation and regulatory compliance, intellectual property rights, strategic relationships with third parties, environmental liabilities, and other risks and uncertainties, including those detailed from time to time in our periodic reports filed with the Securities and Exchange Commission, including our current reports on Form 8-K, quarterly reports on Form 10-Q and annual report on Form 10-K, particularly the discussion under the caption "ITEM 1A, RISK FACTORS." We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

Solvay expands development pact with Wyeth

Wed, 10 Jan 2007 19:01:35 -0500

Solvay and Wyeth Pharmceutical are expanding their existing neuroscience co-development and co-commercialization agreement to include research in neuroscience. The neuroscience co-development and co-commercialization partnership announced in April 2004 between Solvay and Wyeth resulted in an NDA for bifeprunox for the treatment of patients with schizophrenia. Meanwhile development continues on two other early-phase neuroscience projects, SLV313 and SLV314, which were part of that agreement.

- check out the release on the deal

Related Articles:
Solvay earns $25M as obesity drug advances. Report
Wyeth licenses Pharmacopeia's JAK3 program. Report

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: Targacept to Receive $20M Milestone Payment as AstraZeneca Plans to Continue Development of AZD3480

Maureen Martino — Thu, 28 Dec 2006 12:26:13 -0500

Targacept to Receive $20 Million Milestone Payment as AstraZeneca Plans to Continue Development of AZD3480 (TC-1734)

WINSTON-SALEM, N.C., Dec. 27 -- Targacept, Inc. today announced that AstraZeneca plans to continue development of AZD3480 (TC-1734) in Alzheimer's disease and cognitive deficits in schizophrenia. AstraZeneca's determination to continue development triggers a $20 million milestone payment to Targacept under the parties' collaboration agreement. Today's announcement follows the completion by AstraZeneca of previously disclosed studies of AZD3480 (TC-1734).

"AstraZeneca is committed to developing innovative therapies in the areas of unmet need of Alzheimer's disease, schizophrenia and other cognitive disorders. Our decision to continue clinical development of AZD3480 demonstrates our belief in the cognitive-enhancing potential of NNR-targeted therapeutics," said Bob Holland, Vice President and Head of the Neuroscience Therapy Area, AstraZeneca. "In addition to the promise of AZD3480, we are very pleased with our research collaboration with Targacept. We entered into the collaboration excited about the prospects of combining Targacept's longstanding leadership position in NNR research with our existing strengths, and the progress made in a relatively short time has been impressive."

"We are delighted with AstraZeneca's plans to move forward with development of AZD3480 in these two areas where a significant medical need is clear. We believe that the effects on cognition that we observed in our previous nine clinical trials of this product candidate in approximately 400 subjects show its potential as a treatment for cognitive disorders," said J. Donald deBethizy, Ph.D., President and Chief Executive Officer of Targacept. "We are very pleased that AstraZeneca made the determination to conduct further development of AZD3480 ahead of schedule, demonstrating a strong commitment to the NNR mechanism and an extraordinary ability to execute against aggressive timelines. We look forward to a long and productive collaboration."

Alzheimer's disease represents an area of great medical need in the developed and developing world, causing great distress to patients and their caregivers and imposing a major financial burden. Current treatments have limited efficacy and significant side effects in many patients.

Schizophrenia is a chronic, severe and disabling form of psychosis that, in addition to symptoms such as delusions and hallucinations, is often marked by impairments in cognitive functions such as attention, vigilance, memory and reasoning. These cognitive impairments play a primary role in the inability of schizophrenic patients to function normally. There is currently no product approved for the treatment of cognitive deficits in schizophrenia.

Collaboration Summary

In December 2005, Targacept and AstraZeneca entered into an exclusive global license and research collaboration agreement for the development and commercialization of Targacept's proprietary compound TC-1734, which AstraZeneca refers to as AZD3480, to treat Alzheimer's disease, cognitive deficits in schizophrenia and other cognitive disorders. Targacept received an initial payment of $10 million from AstraZeneca and, as a result of AstraZeneca's determination to continue development of AZD3480, a milestone payment of $20 million from AstraZeneca will become due. In addition, Targacept is eligible to receive other payments of up to $249 million, contingent upon the achievement of development, regulatory and first commercial sale milestones for AZD3480, as well as stepped double digit royalties dependent on sales achieved following regulatory approval.

Under the agreement, Targacept and AstraZeneca initiated a preclinical research collaboration in January 2006 under which Targacept is utilizing its proprietary drug discovery technology known as Pentad(TM) to discover additional compounds. Based on the current budget for the research collaboration, Targacept expects to receive approximately $26.4 million in funding from AstraZeneca over the planned four-year research term.

AstraZeneca is primarily responsible for and has agreed to fund the development and commercialization of AZD3480 and any compounds that arise out of the research collaboration. If compounds that arise out of the research collaboration are selected for advancement, Targacept would be eligible to receive additional payments, contingent upon the achievement of development, regulatory and first commercial sale milestones, as well as royalties dependent on sales achieved following regulatory approval. Targacept has retained an option to co-promote in the United States AZD3480 and any compounds that arise out of the research collaboration and are selected for advancement.

Independent of the research collaboration, the agreement provides for a mechanism by which Targacept can offer to AstraZeneca compounds that act on different NNR subtypes than AZD3480 for development and commercialization for the treatment of Alzheimer's disease, cognitive deficits in schizophrenia, other cognitive disorders or schizophrenia.

About Targacept

Targacept is a clinical-stage biopharmaceutical company that discovers and develops NNR Therapeutics(TM), a new class of drugs for the treatment of central nervous system diseases and disorders. Targacept's product candidates selectively modulate neuronal nicotinic receptors that serve as key regulators of the nervous system activity to promote therapeutic effects and limit adverse side effects. Targacept has product candidates in development for Alzheimer's disease and cognitive deficits in schizophrenia, pain and depression, and multiple preclinical programs. Targacept is located in Winston-Salem, North Carolina. For more information about Targacept, please visit www.targacept.com

About AstraZeneca

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of $23.95 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index. For more information about AstraZeneca, please visit www.astrazeneca.com

In Neuroscience, AstraZeneca is dedicated to providing medicines that have the potential to change patients' lives. The company already markets several products including SEROQUEL and ZOMIG. The AstraZeneca neuroscience pipeline includes leading approaches for the treatment of depression and anxiety, schizophrenia, dementia, pain control and anaesthesia.

Forward Looking Statements

Any statements in this press release about expectations, plans and prospects for Targacept, Inc., including, without limitation, statements regarding the development plans and objectives for AZD3480 (TC-1734), the progress, timing and scope of the research and development program, or related regulatory filings or clinical trials, for AZD3480 or any of our other product candidates and all other statements that are not purely historical in nature, constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words "may," "will," "could," "would," "should," "expect," "intend," "plan," "anticipate," "believe," "estimate," "predict," "project," "potential," "promise," "continue," "ongoing" and similar expressions are intended to identify forward-looking statements. Actual results may differ materially from those expressed or implied by forward-looking statements as a result of various important factors, including our critical accounting policies and risks and uncertainties relating to: the amount and timing of resources that AstraZeneca devotes to the development of AZD3480; AstraZeneca's right in the future to terminate the preclinical research collaboration that we and AstraZeneca are currently conducting prior to the end of the planned four-year term; the results of nonclinical studies and assessments and clinical trials with respect to our current and future product candidates in development; the conduct of clinical trials, including the performance of third parties that we or AstraZeneca engage to execute the trials and difficulties or delays in the completion of patient enrollment or data analysis; and the timing and success of submission, acceptance and approval of regulatory filings. These and other risks and uncertainties are described in greater detail under the heading "Risk Factors" in our most recent Quarterly Report on Form 10-Q and in other filings that we make with the Securities and Exchange Commission. As a result of the risks and uncertainties, the results or events indicated by the forward-looking statements may not occur. We caution you not to place undue reliance on any forward-looking statement. In addition, any forward-looking statements in this release represent our views only as of the date of this release and should not be relied upon as representing our views as of any subsequent date. We anticipate that subsequent events and developments may cause our views to change. Although we may elect to update these forward- looking statements publicly at some point in the future, whether as a result of new information, future events or otherwise, we specifically disclaim any obligation to do so, except as required by applicable law. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may make.

Press Release: Eli Lilly Responds to New York Times Article

Maureen Martino — Sun, 17 Dec 2006 11:51:56 -0500

INDIANAPOLIS, Dec 16, 2006 -- Eli Lilly and Company, in a response to a story about Zyprexa in the December 17, 2006 edition of the New York Times, adds important facts and perspectives that were not evident in the story.

Said Steven Paul, M.D., Lilly's executive vice president of science and technology, "We believe it is critical to physicians and patients that Lilly state some important and relevant facts about our lifesaving medication Zyprexa that are missing from the New York Times article:

"First, contrary to incorrect statements in the Times article, Lilly has conducted more than 23 years of research on Zyprexa. And in the last ten years that the drug has been on the market, Lilly, government bodies such as the National Institute of Mental Health, and competitors -- in numerous studies that sought to show a causal link to Zyprexa and diabetes -- have not found that Zyprexa causes diabetes.

"Second, Zyprexa was approved by the FDA in 1996 and remains on the market today. In that time, it has been used by more than 20 million people worldwide, and doctors continue to prescribe it to deal with some of the most terrible mental illnesses, such as schizophrenia and bipolar disorder. The FDA has looked at the entire body of evidence that Lilly has continued to provide over the years, and has affirmed the benefit that this medicine can give to patients when accompanied by appropriate labeling regarding benefits and risks.

"Third, from the day that Zyprexa was approved, the labeling provided to physicians identified the potentially clinically-significant weight gain that was observed in more than half of all patients treated long-term with Zyprexa, as well as the diabetes-related adverse events observed in clinical trials.

"Fourth, the Times failed to mention that these leaked documents are a tiny fraction of the more than 11 million pages of documents provided by Lilly as part of the litigation process. They do not accurately portray Lilly's conduct. As part of Lilly's commitment to patients and healthcare professionals, many high-level Lilly physicians and researchers -- along with researchers from outside Lilly -- were engaged for a number of years to study the issue of Zyprexa and diabetes. Leaked documents involving these discussions do not represent an accurate view of company strategy.

"And, finally, Lilly deplores the illegal release of select confidential documents. Our concern is that this illegal and selective disclosure of incomplete information will cause unwarranted concern among patients that may cause them to stop taking their medication without consulting a physician. This is the unfortunate result we saw when plaintiffs' lawyers aggressively advertised about Zyprexa in recent years while searching for clients."

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers -- through medicines and information -- for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com.

Press Release: Athenagen Initiates Phase II Clinical Trial in Alzheimer's Disease

Maureen Martino — Tue, 12 Dec 2006 13:10:58 -0500

Athenagen Initiates Phase II Clinical Trial in Alzheimer's Disease

Dec 13, 2006 SOUTH SAN FRANCISCO, CA -- Athenagen, Inc., a privately held biopharmaceutical company focused in the area of neurovascular diseases, announced today the commencement of a Phase II clinical study of the company's lead compound, GTS-21, in patients with Alzheimer's disease. GTS-21, a novel, orally active alpha-7 nicotinic acetylcholine (nACh) receptor agonist, was previously demonstrated to improve cognition in a proof-of-concept study in patients with schizophrenia and in healthy volunteers.

"In preclinical and clinical studies, GTS-21 has shown positive benefits in the ability to improve attention, learning and memory impairment, all of which are debilitating cognitive deficiencies associated with numerous medical conditions," said W. Scott Harkonen, M.D., Athenagen President and Chief Executive Officer. "We are excited to advance GTS-21 in Alzheimer's disease as part of our broader strategy to establish efficacy of this product in multiple cognitive deficiencies; initially Alzheimer's disease, ADHD and schizophrenia."

The current Phase II clinical trial is a placebo-controlled, double-blind, randomized dose-ranging study designed to evaluate both safety and cognitive effects in patients with early Alzheimer's disease. More than 4.5 million older Americans have Alzheimer's disease, a condition of aging that affects both memory and learning abilities. The 60-patient study is being conducted by Sheldon H. Preskorn, M.D., Professor and Chair for the Department of Psychiatry and Behavioral Sciences at the University of Kansas School of Medicine, Wichita. Athenagen expects to complete this trial in the second quarter of 2007.

Initial results from a proof-of-concept study in patients with schizophrenia were published in the June issue of the Archives of General Psychiatry (2006; 63:630-638), a peer-reviewed publication of the American Medical Association. The NIH-funded study was conducted by Dr. Robert Freedman, Professor and Chairman of the Department of Psychiatry at the University of Colorado Health Sciences Center.

About GTS-21

GTS-21 (also known as DMBX-A) is a novel, small-molecule, orally active and selective alpha-7 nicotinic acetylcholine (nACh) receptor agonist that has demonstrated memory and cognition enhancement activity in human clinical trials. GTS-21 has been studied in multiple Phase I studies in healthy volunteers and one Phase I/II study in schizophrenic patients. In all studies, the compound was well tolerated. In a Phase I multi-dose, double-blind, placebo-controlled study in healthy adults, GTS-21 also demonstrated cognitive enhancement across all doses, with a statistically significant improvement in attention- and memory-related tasks (Kitagawa, et al. Neuropsychopharmacology (2003), 28, 542-551).

About Athenagen

Athenagen, Inc., located in South San Francisco, is engaged in the discovery and development of small-molecule drugs to treat neurovascular disease indications, such as Alzheimer's disease, AMD and cognitive disorders. The company has two fundamental technology platforms: (i) beta-secretase inhibitors for the treatment of Alzheimer's disease; and (ii) nACh receptor agonists and antagonists for the treatment of angiogenesis mediated diseases and cognitive disorders. Athenagen currently has four product development programs based on these two technologies: ATG003, a topical (eye drop) anti-angiogenesis compound for neovascular AMD in a Phase I study; GTS-21, an oral agonist of the alpha-7 nACh receptor pathway for cognition enhancement currently in a Phase II study; ATG002, a topical (gel) pro-angiogenesis compound for diabetic foot ulcers currently in a Phase I/II study; and multiple clinical candidates from the beta-secretase inhibitor program approaching Phase I/II study for Alzheimer's disease in 2007. For more information: www.athenagen.com.

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.