Enrolling of Phase 2(b) participants expected on March 31 (Nasdaq:ALNY)

Alnylam Pharmaceuticals, Inc. (Nasdaq:ALNY) is a biopharmaceutical company that specializes in providing RNA-based treatment. It has a number of innovative products under its pipeline, and the number is increasing with each passing year. Even in 2009, it has been developing four drugs – ALRN-RSV, ALN-TTR, ALN-PCS and ALN-VSP. The company wants to bring all these into the markets of the United States of America soon – possibly, this year. However, before that, it must gain approval from the country’s toughest regulator – namely, the Food and Drug Administration (FDA). All the four trials are at varying stages of development. For instance, the company has already started conducting the Phase 2 clinical trial ALN-RSV (or ALN-RSV01). The Phase 2 trial comprises of two trials: the Phase 2a and the Phase 2b. The Phase 2a trial was already completed last year. Now the drug is in the second Phase 2 trial. However, conducting the trial is not an easy task – mainly because a large number of participants are required for the trial. And all the participants must be adults who are suffering from lung transplant infected with Respiratory Syncytial Virus (RSV). The company has announced – on January 11, 2010 – that it would start finding the patients “within the first quarter” of 2009. Since no specific date has yet been announced by the company, all the stakeholders believe that most, if not all, participants would be enrolled within March 31, 2010.

The company aims to achieve the same results as it did in Phase 2a trial. It also plans to have a detailed analysis of the results obtained in Phase 2a trial. Both the trials targeted the same segment of patients – that is, people suffering from lung transplant. Meanwhile, the company has confirmed that all the trials and other development activities for RSV01 have been solely funded by Alnylam itself – and not by its partner Cubist. However, the two partners have agreed to equally share the costs associated with developing ALN-RSV01. One thing to note here is that Kyowa Hakko Kirin Co., Ltd. – which is the company’s partner in the region of Asia – is not providing any help with funding.

The reason why Alnylam alone fund the development of RSV01 can be attributed to its strong financial position. Patricia Allen, who is the Vice President of the company’s Finance and Treasurer Department, said:

“We are on track to meet our guidance of ending 2009 with a cash position of greater than $430 million, a financial position that allows us to invest in the advancement of our platform and pipeline of novel RNAi therapeutic products. We expect to finish 2010 with greater than $325 million in cash, which excludes the potential payment from Novartis should they decide to execute their adoption license later this year.”