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News Breaks
January 13, 2014
05:21 EDTALNY, SNYAlnylam, Genzyme form transformational alliance for RNAi therapeutics
Alnylam Pharmaceuticals (ALNY) and Genzyme, a Sanofi company (SNY), announced that they have formed a transformational alliance for the development and commercialization of RNAi therapeutics as genetic medicines. Alnylam will retain product rights in North America and Western Europe, while Genzyme will obtain the right to access Alnylam’s current “5x15”1 and future genetic medicines pipeline in the rest of the world, or ROW, including global product rights for certain programs. In addition, Genzyme becomes a major Alnylam shareholder through an upfront purchase of $700M of newly issued stock at approximately $80/share, representing an approximately 12% ownership position. This alliance significantly bolsters Alnylam’s balance sheet to over $1B in cash, enabling an increased investment in the company’s RNAi therapeutics pipeline and is expected to secure Alnylam’s financial independence through to multiple product launches. Upon the closing of the transaction, Genzyme will opt-in to patisiran, or ALN-TTR02, – an RNAi therapeutic currently in a Phase 3 trial for the treatment of transthyretin, or TTR-mediated amyloidosis, or ATTR patients with Familial Amyloidotic Polyneuropathy – for its ROW territories, while Alnylam retains full product rights in North America and Western Europe. Alnylam and Genzyme have also agreed to expand their current collaboration on ALN-TTRsc – an RNAi therapeutic currently in a Phase 2 trial for the treatment of ATTR patients with TTR amyloid cardiomyopathy – where the parties will co-develop and co-promote ALN-TTRsc in North America and Western Europe; Alnylam will maintain development and commercialization control with ALN-TTRsc and Genzyme will develop and commercialize the product in its ROW territories. The companies believe that this broadened collaboration on ALN-TTRsc will increase the product’s overall value, as significant market development and commercial operational scale is warranted to maximize the opportunity for both familial cardiac amyloidosis senile systemic amyloidosis manifestations of TTR cardiac amyloidosis.
News For ALNY;SNY From The Last 14 Days
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September 30, 2014
10:53 EDTSNYRegeneron dupilumab opportunity improved with new data, says Piper Jaffray
Piper Jaffray said it is increasingly optimistic about dupilumab's broad potential in allergic diseases following the Phase II data on chronic sinusitis with nasal polyps as well as prior data in atopic dermatitis and asthma. The firm views dupilumab as a potential blockbuster and reiterates its Overweight rating and $382 price target on Regeneron (REGN), which announced the data in partnership with Sanofi (SNY).
07:30 EDTSNYSachs Associates to hold a conference
14th Annual Biotech in Europe Forum for Global Partnering and Investment to be held in Basel, Switzerland on September 30-October 1.
05:16 EDTSNYRegeneron, Sanofi announce positive Phase 2 top-line dupilumab results
Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that a Phase 2a proof-of-concept study of dupilumab, an investigational therapy that blocks IL-4 and IL-13 signaling, met all primary and secondary endpoints in patients with moderate-to-severe chronic sinusitis with nasal polyps, or CSwNP, who did not respond to intranasal corticosteroids. In the study, dupilumab resulted in a statistically-significant improvement in the size of nasal polyps, as measured by endoscopic Nasal Polyp Score, the primary endpoint of the study. Statistically significant improvements in all secondary efficacy endpoints were also observed, including objective measures of sinusitis by CT scan, nasal air flow, and patient-reported symptoms. In a pre-specified exploratory analysis, dupilumab-treated patients who also had asthma demonstrated significant improvements in asthma control. The safety profile was consistent with previous studies. The most common AEs with dupilumab were injection site reactions, nasopharyngitis, oropharyngeal pain, epistaxis, headache and dizziness.
September 26, 2014
07:32 EDTALNYBioCentury to hold a conference
21st Annual NewsMakers in the Biotech Industry Conference to be held in New York on September 26.
September 24, 2014
17:01 EDTSNYMannKind announces closing of global licensing agreement with Sanofi
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08:10 EDTSNYSanofi unit announces research collaboration
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08:08 EDTALNYAlnylam initiates DISCOVERY trial
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September 23, 2014
09:00 EDTSNYBofa/Merill special situations team to hold an analyst/industry conference call
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September 22, 2014
07:21 EDTSNYEBD Group to hold a conference
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September 18, 2014
07:49 EDTALNYAlnylam resumed with an Outperform at Leerink
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September 17, 2014
06:18 EDTSNYSanofi, MyoKardia announce collaboration
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September 16, 2014
08:02 EDTALNYAlnylam presents ALN-CC5 pre-clinical data
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07:33 EDTSNYMylan initiates Phase III clinical trials for Advair Diskus and Lantus
Mylan (MYL) announced it is initiating Phase III clinical trials for its generic version of GlaxoSmithKline's (GKS) Advair Diskus and its insulin analog to Sanofi's (SNY) Lantus. In October Mylan will commence a Phase III clinical trial to evaluate the equivalence of its product to Advair Diskus when administered by inhalation in adult asthma patients.

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