Biogen Idec (BIIB) and Genentech, Inc., a wholly-owned member of the Roche Group (RHHBY.PK), announced that they have received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) for Rituxan. The companies were seeking approval for the use of Rituxan (rituximab) plus fludarabine and cyclophosphamide (FC) in patients with previously untreated [...]

(BIIB) Biogen’s Rituxan Label Expansion Delayed

By Dr. George Huang It's hard to find winners in the nightmarish health care reform bill passed by the House... The bill doesn't address the major complaint of the American consumers – soaring costs. In fact, health insurers already predict skyrocketing premiums next year. Instead, the bill forces most employers to provide health care coverage or pay a tax penalty of up to 8% of payroll. The added cost will crush many small businesses.[More...]

Biogen Idec (BIIB) and Genentech, Inc., a wholly-owned member of the Roche Group (RHHBY.PK), announced that they have received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) for Rituxan. The companies were seeking approval for the use of Rituxan (rituximab) plus fludarabine and cyclophosphamide (FC) in patients with previously untreated and treated chronic lymphocytic leukemia (CLL).
 
Although the companies did not provide any details regarding the letter, they said that the agency has not asked them to submit any new data. Genentech and Biogen intend to work towards gaining final approval for the expanded indication and are planning to continue final label discussions with the FDA.
 
Rituxan is currently approved for the treatment of rheumatoid arthritis and non-Hodgkin’s lymphoma (NHL), a type of cancer. It contributes significantly to Biogen’s top line. Biogen receives a profit-split on U.S. sales of Rituxan from Genentech, plus a royalty on international sales and reimbursement on development work. In 2008, the company recognized $1,128 million (up 22%) in Rituxan revenues. To keep the solid growth up, both companies are working to expand Rituxan beyond its current use.
 
According to the American Cancer Society, CLL is the most common form of adult leukemia, accounting for one-third of all leukemia in the United States. About 90,000 Americans are living with CLL and it is estimated that more than 15,000 new cases will be diagnosed this year. Current treatments for CLL include Cephalon’s (CEPH) Treanda, GlaxoSmithKline’s (GSK) Leukeran and Bayer’s (BAYRY.PK) Campath.
 
We currently have a Neutral recommendation on Biogen. The company is the market leader in therapies for the treatment of multiple sclerosis (MS) and we believe that Biogen will continue to retain a leading position in the MS market
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Alnylam Pharmaceuticals Inc. (ALNY) reported a third-quarter loss of 22 cents per share, below the Zacks Consensus Estimate of 24 cents but wider than the year-ago loss of 7 cents. The higher loss in the quarter is attributable to higher stock based compensation and legal expenses. Revenues for the quarter came in at $24.2 million as against $25.7 [...]

(ALNY) Alnylam Pharmaceuticals Posts Wider Loss

Alnylam Pharmaceuticals Inc. (ALNY) reported a third-quarter loss of 22 cents per share, below the Zacks Consensus Estimate of 24 cents but wider than the year-ago loss of 7 cents. The higher loss in the quarter is attributable to higher stock based compensation and legal expenses.

Revenues for the quarter came in at $24.2 million as against $25.7 million in the year-ago quarter, down 5.8%. Research and development costs increased 5% to $23.2 million primarily because of increased costs for clinical and pre-clinical programs coupled with increased R&D headcount to support Alnylam’s alliances and development programs. 
 
General and administrative expenses increased 56% to $10.7 million. The increase in general and administrative spend was primarily driven by higher professional service fees in association with business activities, primarily legal activities, coupled with increased stock based compensation expenses.
 
Alnylam exited the quarter with $453.5 million in cash, cash equivalents and marketable securities and no debt compared to $512.7 million at the end of 2008. We are comfortable with the company’s current cash position, which allays our concern about its cash burn rate. Alnylam expects to end the year with cash, cash equivalents, and marketable securities balance in excess of $430 million.
 
Alnylam Pharmaceuticals, headquartered in Cambridge, Massachusetts, focuses on developing novel therapeutics based on a biological breakthrough known as RNA (Ribo Nucleic Acid) interference (RNAi). The company has entered into collaborations or deals with big pharmaceutical players like Novartis (NVS), Biogen Idec (BIIB), Roche and Takeda  to further develop and utilize its core technology. The partnerships with major players further validate the potential and viability of the RNAi approach. We believe the company will continue to form new alliances with leading pharmaceutical and biotech companies in future.
 
Currently, we are Neutral on Alnylam.

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