Cephalon

ImmuPharma pockets $15M for Lupuzor option

John Carroll — Tue, 25 Nov 2008 10:40:48 -0500

Cephalon has agreed to pay London-based ImmuPharma $15 million for an option on the worldwide rights to its experimental lupus drug Lupuzor. Lupuzor is currently in a mid-stage trial at sites in Latin America and Europe.

If the Phase IIb is successful and Cephalon takes up the option, ImmuPharma would be in line for a deal worth up to $500 million in fees, milestones and future royalties. Cephalon would also be responsible for Phase III testing expenses.

"We are excited about entering another specialty market and the potential Lupuzor presents for us to further diversify our product portfolio and to bring the first specific medication for the treatment of lupus to patients living with this chronic, potentially life-threatening disease," said Frank Baldino, Jr., Ph.D. chairman and CEO of Cephalon (photo). "Our current cash position has created the opportunity to make this type of deal, which helps to position Cephalon and our pipeline for longer term growth."

- read the story from the AP
- read the press release

FDA announces several approvals

Maureen Martino — Mon, 03 Nov 2008 11:27:15 -0500

It's a busy Monday morning at the FDA as the agency announced several approvals. Here's the run-down:

The FDA has approved Pfizer and UCB's Toviaz extended-release tablets for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. UCB gets an undisclosed milestone payment as a result of the approval.
The agency has granted approval for Akorn's ANDA for Adenosine Injection USP for supraventricular tachycardia in cardiac patients.
Cephalon announced that Treanda has been approved for the treatment of patients with indolent B-cell non-Hodgkin's lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.
Salix Pharmaceuticals won marketing approval for Apriso, a drug indicated for the maintenance of remission of ulcerative colitis (UC) in adults.

- see the Toviaz release
- here's Akorn's release
- check out the Treanda release
- see Salix's release

ALSO NOTED: BMS: Buyer or buyout target?; LAB Research readies big expansion;Malaysia readies biotech investments; and much mor

Wed, 07 May 2008 06:59:50 -0400

> Market-watchers love to speculate. Their latest topic? Bristol-Myers Squibb, which has been paring away its "non-core" businesses over the last few months. Report

> Canada's LAB Research has raised $21.1 million to help fund the expansion of its facilities, increasing its floor space from 87,000 to 170,000 square feet. Release

> Canada's Apotex and Intas Biopharmaceuticals have agreed to collaborate on the development of a biosimilar for neutropenia, a side effect of chemotherapy. Report

> ImaRx Therapeutics has forged a deal to sell its urokinase inventory and related assets to Microbix Biosystems for $17 million in cash. Urokinase is an FDA-approved thrombolytic, or clot-dissolving agent. Release

> Isogenica has acquired the principal assets of the Finnish biotechnology company Karyon CTT and secured a £2 million cash investment. Release

> A systems biology spin-off from Newcastle University has opened up a new consultancy division that will use its in-silico technology to assess the safety and efficacy of new drug candidates. E-therapeutics' technology assesses how a drug will respond to cells as well as other therapeutics. Report

> Scientists in Scotland say that they have identified a chemical group that can protect the p53 gene, a guardian against cancer tumors which is damaged or turned off in most cancer cases. Report

> Research on fat cell replacement could lead to new obesity treatments. Report

> An FDA advisory panel voted against broadening the use of Cephalon's painkiller, citing worries that it would in fact be misused. Report

> GlaxoSmithKline went hat in hand to the bond markets and came back with a record $9 billion. Report

And Finally... Malaysian officials are lining up the first big round of loans to the country's biotech sector. Report

Cephalon CEO Frank Baldino

Maureen Martino — Wed, 26 Mar 2008 11:01:51 -0400

Cephalon, investors await FDA Treanda decision

Wed, 19 Mar 2008 07:59:54 -0400

After seeing its stock price shed about a third of its value since last summer, Cephalon is keeping its fingers crossed that tomorrow's scheduled regulatory decision on its cancer drug Treanda can turn things around. At least that's what the analysts are seeing. Some expect a sharp upturn if the agency approves Treanda for chronic lymphocytic leukemia.

"This is the first big step. It will be the foundation for our oncology business," Liz Barrett, vice president of Cephalon's oncology unit, told the Wall Street Journal. Analysts peg its potential in the neighborhood of $250 million a year. But Cephalon is also looking for additional approvals, including using the therapy as an add-on to Rituxan, which could make it a seven-figure market blockbuster.

- here's Cephalon's release
- read the report in the Wall Street Journal

Related Articles:
Cephalon, NitroMed make cuts jobs. Report
Positive Phase III results for Cephalon's Treanda. Report
Cephalon takes heat for off-label narcotic promotion. Report
Cephalon shares tank after Sparlon rejection. Report

ALSO NOTED: ZymoGenetics to chop jobs; Evotec extends collaboration; Iomai touts results for vaccine patch; and much more...

Thu, 14 Feb 2008 06:59:50 -0500

> ZymoGenetics is chopping 80 jobs--mostly in R&D--after facing some tough reviews for the potential of its newly released drug Recothrom--a genetically engineered form of thrombin to prevent surgical bleeding. Several analysts have cast doubt on the future of the drug, which was independently released, as well as ZymoGenetics other lines of research. Those prognostications have weighed heavily on the company's stock at a time the stock market has been roiled by speculation of a looming recession. The Seattle Times also notes that the cutbacks reflect the difficulty biotech companies face when moving from pure research to a combination of R&D and marketing. Release | Report

> Evotec stands to gain up to $37 million through the extension of its collaboration with the CHDA Foundation for new therapies to fight Huntington's disease. Release

> Officials in West Virginia are highlighting a new report that calls for an investment in new drug research, noting that the state is near the bottom of the 50 states in research funding and venture capital. Report

> Iomai is touting the results of a mid-stage study of its vaccine patch for traveler's diarrhea. Report

> Sanofi Pasteur has struck a licensing deal with the Statens Serum Institut of Denmark covering the use of its technology for a new tuberculosis vaccine. Report

> A Chinese plant never inspected by the FDA turned out an active ingredient in the heparin vials recalled last month. The Baxter-made blood thinner has been implicated in hundreds of adverse reactions and four deaths. Now, the FDA is investigating, planning an expedited examination of that plant and its records. Report

> The feds are accusing Cephalon of bribing drug makers to keep copycat Provigil off the market. Report

> Biogen Idec and Cardiokine have launched a late-stage trial of Lixivaptan for congestive heart failure patients suffering from hyponatremia. Release

> Alex Gorsky has left the building. As Novartis' U.S. pharma CEO, Gorsky (photo) had been with the company four years; he's now "pursuing opportunities outside of the company." Report

> It's not personal, it's political. When the Republicans were in charge on Capitol Hill, drugmakers were in favor--or so it appeared to the minority party. Now that the Dems run Congress, they're turning the tables. Report

And Finally… Generic drug makers are enthusiastic about the Bush administration's decision to back a regulatory pathway for follow-on biologics. Article

ALSO NOTED: Cephalon, NitroMed make cuts jobs; IonGate gains funds; and much more...

Wed, 16 Jan 2008 06:59:50 -0500

> Cephalon is cutting jobs as it restructures, shifting manufacturing work from Minnesota to Salt Lake City and relocating some R&D work from Salt Lake City to Minnesota. Report

> NitroMed is in trouble. The company is not only shutting down its sales force and laying off 70 of the 90 people work work there, but asking the investment bank Cowen & Co. to advise it on "strategic alternatives." Report

> IonGate Biosciences has garnered €4.6 million in its third venture round. Heidelberg Innovation and KfW (Kreditanstalt für Wiederaufbau) led the round. Release

> Nycomed is looking for partners in the U.S. following the FDA's approval of Alvesco, its asthma inhaler therapy. Release

> ExonHit Therapeutics has created two commercial business units: the Molecular Diagnostics and Genomic Services Unit and the Therapeutics Unit. Release

> Germany's MorphoSys has acquired patent rights on protein inhibitors from the University of Melbourne, advancing its work on an experimental rheumatoid arthritis therapy. Release

> Teva Specialty Pharmaceuticals and UCB have signed a commercialization pact on Teva's respiratory products. Release

> MAP Pharmaceuticals and the FDA have reached a protocol agreement for a clinical study of MAP0004, a migraine therapy. Release

> Scientists in Singapore are advocating new rules that would permit researchers to splice human DNA into animals to further stem cell research. Report

> Research groups were left shaking their heads in disappointment over news that next year's budget for the National Institutes of Health--the largest single supporter of biomedical research in the U.S.--will boost spending by a meager 0.5 percent. Report

> Science has taken another big step in the direction of building new body organs from stem cells. A team of scientists have constructed a new rat heart, injecting cells from newborn rodents onto a scaffold of valves that were left intact after dead heart cells were removed. Report

> The European Commission has launched a pharma antitrust probe, looking for evidence that industrial hijinks are keeping new products off the market and delaying cheaper generics. Report

> It didn't take long for allegations of improper marketing from two Amgen sales reps to attract the attention of government watchdogs. First, the New Jersey Attorney General formed a task force to investigate pharma-doctor interaction. And now, perpetual pharma bloodhound Sen. Charles Grassley (R-IA) is sniffing around the cases. Report

And Finally... A new genetic test kit is being marketed that will give men an advance warning on going bald. Report

Positive Phase III results for Cephalon's Treanda

Wed, 24 Oct 2007 06:59:57 -0400

Cephalon is touting Phase III results of its non-Hodgkin's lymphoma drug Treanda. In the trial, 100 patients who were not responding to Genentech and Biogen Idec's Rituxan were given Treanda. The overall response rate was 75 percent and the median duration of response was 40 weeks (9.2 months). The study met its primary endpoints of overall response rate and median duration of response, while demonstrating a manageable tolerability profile.

"We are encouraged that these results replicate those seen in our Phase 2 study, confirming the substantial efficacy in this difficult to treat population," said Dr. Lesley Russell, Executive Vice President, Worldwide Medical and Regulatory Operations. "Based on these positive results, we are on track to file a New Drug Application in the fourth quarter for Treanda in patients with indolent NHL who have failed treatment with rituximab." Treanda is also being studied as a treatment for chronic lymphocytic leukemia.

- see this release for more

PLUS: Anthera Pharmaceuticals has reported positive results from a Phase II clinical trial of its first compound, A-002, for the treatment of cardiovascular disease. Release

Related Articles:
Cephalon takes heat for off-label narcotic promotion. Report
Cephalon shares tank after Sparlon rejection. Report

ALSO NOTED: Genzyme has made best offer for Bioenvision; Pfizer wants investigators to pursue ex-employee; GSK licenses IP; and

Thu, 27 Sep 2007 06:59:50 -0400

> Genzyme says its current bid for all the shares of Bioenvision it doesn't already own is its best and final offer. Release

> Pfizer wants the feds to throw the book at a former employee who copied personal data on some 34,000 workers and took it off site. Report

> GlaxoSmithKline has licensed reverse genetics IP for influenza vaccine strains from MedImmune. Release

> Medarex and PharmAthene have received a $14 million contract from the U.S. government to continue funding an anthrax vaccine. Release

> San Diego-based Asphelia Pharmaceuticals has named Francois-Xavier Frapaise, M.D.,as president and CEO. Release

> The FDA issued a warning yesterday on Fentora, the Cephalon painkiller recently linked to three deaths. Report

> As Novartis CEO Daniel Vasella predicted last week, the FDA has rejected the company's Cox-2 painkiller Prexige. Report

And Finally... Researchers at MIT have developed a computer model which they say can rev up the effectiveness of an antibody-based therapy. Report

ALSO NOTED: What to expect from Pfizer's new CFO; BrainStorm plans stem cell trials; Phoenix biotech plans San Diego move; and

Thu, 23 Aug 2007 06:59:50 -0400

> Newtown, PA-based CollaGenex says that it has reaped positive data from a mid-stage study of Col-118 for the treatment of erythema. Release

> BrainStorm Cell Therapeutics says it's on track to become the first developer to win approval for clinical trials on a new Parkinson's therapy that uses adult stem cells extracted from the patient. Report

> Ribomed Biotechnologies says the loss of its Phoenix lab space is forcing a move to San Diego. Report

> Cephalon says it is buying the North American rights to Amrix, a muscle relaxing drug, from ECR Pharmaceuticals for $100 million. Report

> Clinical Data is building its biomarker business with the $11.84 million acquisition of Epidauros Biotechnologie. Release

> Nucryst Pharmaceuticals has named Thomas Gardner as chairman, president and CEO. Release

> Alltracel plans to buy Synpart, an oral care business. Report

> It might sound like a candidate for the So What? award, but the FDA's approval of the "atypical" antipsychotic Risperdal for use in children and adolescents is a landmark decision. Report

> As Frank D'Amelio takes over as Pfizer's financial fix-it guy, what changes are in store for the company? FiercePharma

And Finally… Scientists are deeply skeptical, but China's Beike Biotechnology has been touting miracle cures spurred by stem cell therapies that are still years away from approval in most other countries. Article

ALSO NOTED: Cephalon touts Fentora data; Northfield pursuing PolyHeme approval; FDA accepts NDA; and much more...

Thu, 16 Aug 2007 06:59:50 -0400

> Cephalon is reporting positive results from a study on its pain drug Fentora in non-cancer related pain. Fentora was approved last year for cancer pain. Release

> Even though its blood substitute PolyHeme has been linked to a higher death rate, Northfield Laboratories says it plans to pursue an FDA approval next year in cases where donor blood is not available. Release | Report

> The FDA accepted Summers Laboratories' new drug application for a head lice treatment that's been licensed by Sciele Pharma. The product kills lice through asphyxiation rather than with toxins. Release

> AdventRx Pharmaceuticals says that the FDA has provided fast track status for ANX-510, which is currently being investigated in a Phase III study, with 5-fluorouracil (5-FU) and bevacizumab for the initial treatment of metastatic colorectal cancer. Release

> Methodist Hospital in Houston has launched a bioinformatics project. FierceBioResearcher

> A new study has found that DTC ad spending on the rise. FiercePharma

> Rumor Mill: Novartis may make a bid for Bayer. FiercePharma

And Finally... The experts say that global warming is triggering an increase in flesh-eating diseases and pushing the development of new therapies. Report

Cephalon adding new details about development programs

Thu, 28 Jun 2007 00:01:34 -0400

Hot on the heels of an FDA approval for its narcolepsy drug Nuvigil, Cephalon has been outlining its plans to expand the use of Nuvigil prior to a commercial launch as it further develops programs for fatigue and pain. In advance of the company's R&D day today, analysts were speculating about Cephalon's likely announcement to expand the use of Fentora for pain and focus on its oncology pipeline. The buzz has investors interested. Buyers helped push up the value of Cephalon's shares in the discussion.

- read the AP report on Cephalon

Related Articles:
Cephalon takes careful approach to Nuvigil. Report
FDA approves Fentora for cancer pain. Report
Cephalon takes heat for off-label narcotic promotion. Report

ALSO NOTED: Trisenox demonstrates survival benefits; Cytori shares rise on FDA approval; and much more...

Wed, 24 Jan 2007 19:01:30 -0500

> A new study of Cephalon's Trisenox for acute promyelocytic leukemia demonstrated increased survival time. "The results of this study showing a survival benefit associated with the use of Trisenox in patients with APL are an important development for physicians and patients, as demonstrated by the urgency to disseminate the results to clinicians in an expedited manner," says Dr. Lesley Russell, executive vice president of Cephalon. "We are encouraged by the oncology community's continued interest in the potential of Trisenox, and these study results reinforce Cephalon's commitment to build a fully integrated oncology business." Release

> Shares of Cytori Therapeutics, a stem cell company, got a bump this morning after it announced that the FDA had approved its fat tissue processing system. Report

> The death of a Russian dissident from radiation poison has focused new attention on Ovation Pharmaceuticals Chemet, which treats the symptoms of exposure to radiation. The company says the fresh attention could translate into federal funding. Article

> An EU expert panel has backed approval of Januvia and Xelevia for diabetes as well as the extended use of prevenar and xyrem. Report

> Gentris has received FDA approval for one of its genomics tests. Report

> Resverlogix has retained UBS Securities advise the company on an evaluation of "strategic alternatives." Release

> DOV Pharmaceutical has restructured its debt, exchanging $70 million in debentures for shares and $14.9 million in cash. Release

> Oculus Innovative Sciences has priced its IPO at $8 a share. Release

> Reactivated p53 gene plays role in fighting tumors. Report

> Autoimmune disease research points to new therapies. Report

> Alzheimer's patch used to deliver vaccine to mice. Report

And Finally… British scientists are using robotics to automate stem cell research and quicken the speed of the discovery process. Release

ALSO NOTED: Omeros gets new funding; Positive data released on Fentora; Pfizer inks RNAi deal with Mirus;and much more...

Tue, 09 Jan 2007 19:01:30 -0500

> Seattle-based Omeros Corporation announced that the Stanley Medical Research Institute will provide up to $9 million in equity and grant funding toward the development of Omeros' proprietary drug candidate for the treatment of schizophrenia. The funding is expected to advance Omeros' schizophrenia program through the completion of Phase 1 clinical trials. Release

> Cephalon announced positive results for its pain medication Fentora, saying its effective in treating breakthrough pain in patients with chronic pain. The drug is already approved for patients with cancer pain. Release

> Pfizer has struck a deal with Madison, WI-based Mirus Bio to use its nucleic acid delivery technology in its development of gene silencing (RNAi) therapies. Release

> Atlas Venture has led a first round of venture finance for San Diego-based Proprius Pharmaceuticals that starts at $11 million and scales up to $17 million for new programs. Much of that money will finance the development of Indaflex, a Phase II therapy for osteoarthritis. Release

> Icagen says it is advancing compounds that have worked in animal studies to relieve chronic pain. Report

> Cell Therapeutics has filed a special protocol assessment with the FDA as it prepares a Phase III trial of Xyotax for non-small cell lung cancer. Report

> The EU has approved the use of Roche's Neorecormon for anemia in patients with solid cancers. Report

> Biopure has received a provisional opinion letter from the United Kingdom Commission on Human Medicines containing comments and questions based on its review of the company's marketing authorization application for Hemopure. Release

> Fortune has named its annual list of 100 of the best places to work in the U.S. and included Genentech (third), Amgen and Genzyme. Report

And Finally… Avian flu has dropped off the front page, but there's a new rash of human infections creeping up in Asia. Two new cases have been reported in Indonesia and a farmer in China has fallen ill with the virus. Report

FDA review may force extension of Nuvigil deadline

Wed, 06 Dec 2006 19:01:35 -0500

The FDA is continuing to investigate a case of sometimes fatal rash that developed during a clinical trial of Sparlon, an experimental therapy for sleep disorder, according to an announcement from Cephalon. And that investigation could cause a delay in the agency's decision on Nuvigil, a next-generation therapy that follows Provigil. All three therapies rely on modafinil as the active ingredient. Cephalon says that the time needed to finish the Sparlon review may require an extension of the FDA's Dec. 31 deadline for a decision on its Nuvigil application. The FDA issued an approvable letter for Nuvigil earlier this year.

- here's the report on Cephalon from the Philadelphia Business Inquirer

Related Articles:
Cephalon provides update on Sparlon. Report
FDA committee rejects Cephalon's Sparlon. Report
FDA issues approvable letter for Nuvigil. Report

Cephalon takes heat for off-label narcotic promotion

Mon, 20 Nov 2006 19:01:37 -0500

Connecticut Attorney General Richard Blumenthal has determined that Cephalon "engaged in questionable practices" to increase sales of the narcotic painkiller lollipop Actiq. The drug, which is FDA-approved only for use in treating cancer pain, is widely prescribed for conditions such as migraines and backache as well. With a growing number of patients becoming addicted to Actiq, which contains fentanyl, government regulators and physicians were concerned that marketing tactics were leading to over-use of the drug. Though off-label use is not illegal, the two-year investigation found that Cephalon went too far in promoting Actiq for unapproved uses by setting high sales quotas and pushing higher doses of the drug. According to the Wall Street Journal, the findings "could result in civil charges under the state's patient and consumer protection laws if Cephalon doesn't agree to a settlement." The drug maker's lawyers are meeting with Blumenthal next month to discuss the findings.

- read this Wall Street Journal article for more (sub. req.)

Related Article:
Off-label use of narcotic raises questions. Report

Ablynx inks licensing deal for Nanobodies

Sun, 05 Nov 2006 19:01:37 -0500

Ablynx has agreed to license its Nanobodies technology to Wyeth for tumor necrosis factor alpha (TNF-(alpha)) protein and its receptors in a deal worth up to $212 million in up-front fees and milestone payments. Belgium's Ablynx has been developing small antibodies by cloning the DNA sequences of llamas, which have smaller antibodies than humans. In theory, the technology will take antibodies to a smaller level, allowing their use in drugs that can be taken orally or in creams and sprays.

"Ablynx is an exciting European biotechnology company that has established the feasibility of their novel Nanobody platform by generating Nanobodies to more than twenty different targets," said Dr. Frank Walsh, Executive Vice President, Head of Discovery Research, Wyeth Pharmaceuticals. "We look forward to a productive and long lasting partnership with Ablynx."

- here's the release on the licensing deal

ALSO: Cephalon has agreed to pay an up-front fee of $18 million to Ambit for access to Ambit's proprietary KinomeScan technology. In addition, the companies will collaborate on advancing two programs targeting undisclosed kinases, with Ambit having primary responsibility for delivering clinical candidates that Cephalon will further develop in exchange for additional milestone payments to Ambit of up to $232.5 million and royalties on commercial sales. Ambit will also have the opportunity to utilize Cephalon library compounds to discover and develop products that are effective inhibitors of certain undisclosed kinases. Ambit was a 2006 Fierce 15 company. Release

Related Articles:
Genmab shares up on new antibody tech. Report
Ablynx pockets $50M in third round. Report
New study highlights risks of anti-TNF antibody class. Report

ALSO NOTED: Santhera IPO raises $71M; FDA approves NovaDel's NitroMist; Adventrx selling shares; and much more...

Thu, 02 Nov 2006 19:01:30 -0500

> Santhera's IPO raised $71 million (88.5 million Swiss Francs) after shares began trading today. Report

> The FDA has approved NovaDel's NitroMist for angina. Par Pharmaceuticals holds the North American rights to the drug. "The FDA's approval of NitroMist is a major milestone for NovaDel, as it represents the first approval of a drug using our proprietary oral spray technology," said CEO Jan Egberts. Release

> Adventrx is selling $40 million in shares. Release

> Some analysts are giving Vertex the edge in the race to get a new drug approved for hepatitis C. Report

> The EMEA has given Bradmer Pharmaceuticals' Neuradiab orphan drug status for the treatment of glioblastoma multiforme. Release

> PTC Therapeutics is touting positive Phase II data for its cystic fibrosis therapy PTC124. Release

> Avanir is selling $15 million in common stock. Release

> The FDA is questioning the off-label use of Cephalon's painkiller Actiq, which is approved only for use in treating cancer pain. Report

> Take a peek at the Motley Fool's Biotech Haunted House...if you dare. Report

And Finally... Chinese officials are disputing reports that a new strain of bird flu has emerged in the country. Report (WSJ sub. req.)

Cephalon touts new pain study data

Tue, 10 Oct 2006 20:01:36 -0400

Cephalon announced that a Phase III trial of Fentora demonstrated a statistically significant response for lower back pain. Fentora is approved as a therapy for cancer pain. In the trial, Fentora provided significant relief within 10 minutes compared to a placebo. Fentora is an oral therapy absorbed through the lining of the cheek. Cephalon shares were buoyed by the announcement.

- Here's the AP report on Fentora

FDA approves Fentora for cancer pain

Mon, 25 Sep 2006 20:01:37 -0400

The FDA has approved Cephalon's Fentora for treating the pain of some cancer victims. The agency approved the drug for patients who can tolerate opioid therapy. Fentora includes fentanyl, a powerful pain killer that is used in other therapies as well. But Fentora is designed to be absorbed in the lining of the upper cheek, which researchers say can deliver pain relief much faster than other methods. The agency had already given conditional approval of Fentora, which will be used to treat sharp spikes in pain that can last anywhere from three to 60 minutes. Cephalon is also studying Fentora for other types of pain as well.

- here's a report on the approval from TheStreet.com