BioMed News Bytes: Genzyme, ImmunoCellular, Momenta, Novo Nordisk Print E-mail
Wednesday, 23 September 2009 08:27

On 9/23/09, ImmunoCellular Therapeutics (OTC: IMUC.OB) announced that it completed humanization for a pair of monoclonal antibodies (mAbs), ICT-37 and ICT-109, in collaboration with a privately held, UK-based biotech Antitope.

 

The collaboration has resulted in two novel mAbs that target two commonly expressed genes specific to colorectal cancer, small-cell lung cancer and pancreatic cancer (CEACAM5 alone and CEACAM5 + CEACAM6 in combination). IMUC’s mAbs uniquely target glycosylated (carbohydrate-based) structures present on cancer cells, resulting in the potential for a cancer-targeted treatment that spares healthy cells.

The process of mAb humanization increases the acceptance of these compounds by the immune system and utilizes Antitope’s Composite Human Antibody Technology as a critical step in creating mAbs for therapeutic use / clinical testing in humans. The President / CEO of the Company, Manish Singh, PhD, stated that, “IMUC will retain all rights to the humanized antibodies and will explore partnering opportunities with companies that may be interested in small cell lung, pancreatic and colon cancer targeting opportunities as we continue to seek the fastest path to FDA approval for these potentially revolutionary therapies.”

Dr. Singh has already on one of four short-term catalysts for the Company expected to occur by early 2010 with the Roche pact. Remaining milestones include (1) the development of clinical data for small cell lung cancer detection in serum samples during 3Q09; (2) an IND filing for a Phase I trial for the Company’s offtheshelf cancer stem cell vaccine (ICT121), which is expected during 1Q10; and (3) updated Phase I clinical data for ICT-107, which is possible during 4Q09 pending follow-up with statisticians for the trial and determining the appropriate venue for releasing the data as per Dr. Singh’s reply to my follow-up question at the Rodman conference on this subject.

On 9/23/09, Momenta Pharma (NASDAQ: MNTA) announced the pricing of an underwritten offering of 4 million shares of its common stock at a price of $10.75 per share (with a previous closing price of $11.60 per share). After underwriting discounts and commissions and estimated offering expenses, Momenta expects to receive net proceeds of approximately $40.6 million. All of the shares are being sold by Momenta and the Company has granted the underwriter a 30-day option to purchase up to an additional 600,000 shares of the common stock to cover overallotments.

Momenta provided guidance at the Rodman Healthcare conference two weeks ago that it is cautiously optimistic on the chances for approval of M-Enoxaparin by the end of 2009 and believes that the FDA has all the required data for a decision on the pending ANDA. In addition, MNTA will present full Phase 2a data on its proprietary anti-coagulant compound M118 at an upcoming conference on 9/24/09 while seeking a partnership to fund further clinical development and potential commercialization.

On 9/23/09, Genzyme (NASDAQ: GENZ) provided an update on its progress to restore supplies of Cerezyme (imiglucerase for injection) and Fabrazyme (agalsidase beta) for patients worldwide and revised its 2009 revenue guidance for these products. The company is now approximately half-way through the anticipated shortage period for Cerezyme and Fabrazyme, the restart of the Allston Landing manufacturing facility is complete, and if production continues to proceed as planned, Genzyme expects that it can begin meeting anticipated patient demand for both products during 1Q10.

On 9/23/09, Novo Nordisk (NYSE: NVO) announced the delay until 4Q09 of formal feedback from the FDA for its pending Victoza (liraglutide is a once-daily human GLP-1 analogue) NDA seeking U.S. marketing approval for the treatment of type 2 diabetes in adults. NVO expecs to provide a regulatory update for liraglutide along with its nine-month financial results on 10/29/09 (or sooner if a FDA response is received before this time). On 7/3/09, NVO announced European Commission marketing authorization for (liraglutide) in the treatment of type 2 diabetes in adults.

The original PDUFA action date for the Company's pending Victoza NDA for type 2 diabetes was 3/23/09, but a FDA decision is still pending. Victoza is used once-daily via subcutaneous injection, and the drug is a synthetic glucagon-like peptide-1 (GLP-1) that works by stimulating insulin release when glucose levels become high. On 4/2/09, an FDA Advisory Panel stated liraglutide does not appear to carry heart risks, though serious questions remain about its possible links to tumors. Panelists were split, voting 6-6, on whether the drug should be approved in the face of evidence it caused cancerous thyroid tumors in rats and mice. The panel voted 8-5 in favor of the drug's cardiovascular safety profile.

Disclosure: Long IMUC.OB.

See my full disclaimer at MikeHavRx.com (bottom of any page).




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