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Tuesday, July 9, 2019

Sandoz extends SYMJEPI injection launch to US pharmacies

Sandoz, a Novartis (NYSE:NVS) division, announces the US retail launch of SYMJEPI (epinephrine) 0.3 mg and 0.15 mg Injections. It will be now available in local pharmacies across the nation.
SYMJEPI is a single-dose, pre-filled syringe and device combination as an alternative to epinephrine auto-injectors for the emergency treatment of allergic reactions (Type 1), including anaphylaxis, a severe reaction that can lead to death if left untreated.
Sandoz launched SYMJEPI 0.3 mg Injection in the institutional (hospital) setting earlier this year.

Titan Pharma up on Probuphine distribution deal with CVS

Thinly traded nano cap Titan Pharmaceuticals (NASDAQ:TTNP) is up 12% premarket on light volume in reaction to its agreement with CVS Health unit CVS Caremark for the distribution of its Probuphine (buprenorphine) implant for the treatment of opioid use disorder.
Financial terms are not disclosed.

Allscripts offers a new platform for health data transition

Allscripts Healthcare Solutions (NASDAQ:MDRXannounces FollowMyHealth, as a platform for existing Microsoft HealthVault users to transition and share their health data with family, friends or their home care team when required.
FollowMyHealth offers an option to export their existing data and continue tracking their health online or through its mobile apps. HealthVault will be retired on November 20.

Bayer approached Elanco about possible deal

Bloomberg reports that Bayer (OTCPK:BAYRY +1.4%) recently contacted Elanco Animal Health (ELAN +2.1%) about a possible deal.
Bayer’s animal health unit generated €421M (+1.7%) in sales in Q1, representing 3.2% of the company’s overall revenues.
Elanco, spun out of Eli Lilly last year, generated $731M in sales in Q1.
Update: According to the Financial Post, the companies are discussing a merger. Bayer’s motivation is raising cash after its $63B takeout of Monsanto.

Pulmatrix up on advancement of mid-stage Pulmazole study

Nano cap Pulmatrix (PULM +4.4%) is up on below-average volume following its announcement that three sites in the U.S. have been activated for its Phase 2 study of Pulmazole for the treatment of allergic bronchopulmonary aspergillosis in asthma patients.
17 of the 25 treatment sites are in the U.S., UK and Australia. The remaining eight are in India and Poland.

Sage Therapeutics gains as Stifel touts pipeline

Stifel is bullish (BUY/$240) on Sage Therapeutics (SAGE +4.8%) based on its pipeline prospects.
A key future data readout is lead drug SAGE-217 in major depressive disorder. Other indications in development include bipolar depression, postpartum depression and insomnia.
Candidate #2, SAGE-324, is its Phase 1-stage program for Parkinson’s, essential tremor and epileptiform disorders.
The just-started commercial launch of Zulresso (brexanolone) should, no doubt, contribute to Stifel’s rosy outlook.
Sage is scheduled deliver another pipeline update on July 24.
SA Authors rating is Bullish while the Quant rating is Neutral.

Amarin hit on third citizen petition to invalidate key Vascepa patent

Amarin (AMRN -5.1%) is down on more than double normal volume in what appears to be profit-taking after its 33% rally since late June.
Many observers are attributing today’s drop to the filing of a third Citizen Petition by Medical Research Collaborative, LLC requesting that the company’s U.S. Patent No. 8,188,146 covering the composition of highly purified ethyl eicosapentaenoic acid (EPA) and other EPA derivatives, be removed from the FDA’s Orange Book (ultra-pure omega-3 fatty acid is the active ingredient in Vascepa).
On May 31, 2016, the FDA awarded Amarin five years of New Chemical Entity (NCE) exclusivity for Vascepa, meaning that icosapent ethyl should not contain any active moiety previously approved by the agency. As the patent title states, though, icosapent ethyl is an ethyl ester of EPA. GlaxoSmithKline’s Lovaza (omega-3-acid ethyl esters) is a combination of seven ethyl esters of omega-3 fatty acids so many have argued that the agency erred in granting NCE exclusivity for Vascepa, the removal of which would open the floodgates for competitors.