Drug Pipeline Pulse Check: Landmark Approval for Dendreon
DENDREON Corp (DNDN)
The FDA’s landmark approval of Dendreon’s prostate cancer vaccine, Provenge, has been warmly welcomed by analysts. After being rejected three years ago, the approval of the drug marks a significant breakthrough for cancer treatment and research. The vaccine, which allows a patient to use their own immune system to fight the disease, could also bring in huge profits for the Seattle-based biotech company.
Analysts rushed to raise the firm’s stock target price and revenue forecasts as sales for the drug could easily top $1 billion a year. Needham & Company lifted Dendreon’s price target to $62 from $38 and maintained their “buy” rating. (StreetInsider) Brean Murray Carret & Co analyst Jonathan Aschoff upped its price target to $65 from $50 and forecast annual Provenge sales of $1.45 billion in 2013 based on a higher-than-expected price, with peak sales topping $2 billion. (Reuters)
Provenge may reap annual sales of $4.3 billion by 2020, said Canaccord Adams analyst George Farmer, and its clearance will benefit more than a dozen other companies developing drugs in the emerging field of cancer immunotherapy, said Joseph Pantginis, an analyst with Roth Capital Partners. “…Its truly a landmark event,” he said. (Bloomberg)
With several other cancer vaccines in the pipeline, Dendreon is now the “anchor tenant” that Seattle’s biotech community has lacked, said David Miller, president of Biotech Stock Research. “This is huge for Seattle,” he said. (Seattle Times)
The approval of Provenge was also huge for SAC Capital, which made about $100 million in one day on Dendreon, according to Business Insider.
BRISTOL-MYERS SQUIBB (BMY)
Awaiting regulatory approval for at least five experimental drugs, Bristol-Myers Squibb CEO Lamberto Andreotti said the company’s ambitious plans for new drugs will prevent it from seeing earnings decline after their patents expire for Plavix and Avapro in 2012. (BNET)
The Cardiovascular and Renal Advisory Committee suggested that the FDA should approve Bristol-Meyers’ Belatacept, used for patients with kidney transplants. A decision is expected on May 1, and Leerink Swann analyst Seamus Fernandez is forecasting $650 million in sales by 2016. Expand the pool to other transplant organs and Fernandez’s estimate could prove conservative, according to BNET’s David Phillips.
In March, Bristol and announced that the FDA has accepted for review an investigational fixed dose combination of onglyza and metformin HCL, extended-release tablets as a once-daily treatment for Type 2 diabetes in adults. A decision by the FDA is expected October 29 this year.
Bristol’s phase III results for Ipilimumab in metastatic melanoma and Sprycel for the first-line treatment of chronic myeloid leukemia have been accepted for presentation by the American Society of Clinical Oncology. Results of a Phase III study of Dapagliflozin for the treatment of Type 2 diabetes are planned for presentation at the American Diabetes Association scientific sessions and new data for Belatacept will be presented at the American Transplant Congress. (Drugs.com)
An advanced stage 2 study also showed that Apixaban, an oral blood thinner being co-developed with Pfizer (PFE) may have lower bleeding risk compared to enoxaparin, or Lovenox, a similar drug currently on the market and sold by French drug maker Sanofi-Aventis (SAN).
In the second half of 2010, Bristol and Pfizer are on track to seek regulatory approval in Europe for the prevention of blood clots in patients undergoing orthopedic surgery.
With $10 billion in cash, Tim Anderson, analyst at Sanford Bernstein said in a note last month that although Bristol-Meyers has continued to say it would only pursue smaller acquisitions, “We continue to wonder whether a larger transaction might ultimately occur.” (BNET)
PFIZER (PFE)
Pfizer currently has three new biotech projects in mid-stage development, according to the Wall Street Journal. The pharma giant is trying to create improved versions of its best-selling biotech drugs, also known as biologics – large and complex molecules derived from living cells, rather than the small chemical molecules that form traditional drugs.
Two of the drugs are meant to become improvements on Rituxan, a treatment for certain blood cancers and rheumatoid arthritis. The drug is also being co-marketed by Roche Holding (RO) and Biogen Idec (BIIB). The third one seeks to reduce the number of injections needed for arthritis medicine like Enbrel, a drug co-marketed by Amgen (AMGN).
POZEN Inc. (POZN)
Pozen announced Friday that the FDA has approved its Vimovo arthritis drug. Vimovo is a fixed-dose combination of enteric-coated naproxen, a pain-relieving non-steroidal anti-inflammatory drug (NSAID) and immediate release esomeprazole, a proton pump inhibitor (PPI), under investigation for the treatment of the signs and symptoms of osteoarthritis (OA), rheumatoid arthritis (RA) and ankylosing spondylitis (AS) in patients who are at risk of developing NSAID-associated gastric ulcers.
Analyst Jonathan Aschoff of Brean Murray, Carret & Co. projects that annual worldwide Vimovo sales could peak at $800 million, generating about $80 million in royalty revenue for Pozen. By comparison, Pozen’s revenue from royalties and milestone payments totaled $32.2 million for all of last year. (Drugs.com)
Pozen shares have nearly doubled since the beginning of March, driven largely by anticipation of a positive outcome for Vimovo. However, they took a dip prior to the announcement on fears the FDA approval would not be forthcoming.
Pozen said it will get an immediate $10 million milestone payment from partner AstraZeneca(AZN) with more to come.
Sheena Lee
This post was based on an Advanced Search of Alacra Pulse:
Industry: pharmaceuticals, biotech
Street Pulse: include any analyst comment
Keywords: FDA OR pipeline (select Boolean)
Date: past 7 days
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