Yesterday, 3:52 PM
- Burlington, MA-based CoLucid Pharmaceuticals (Pending:CLCD) is set for its IPO of 5.36M shares of common stock at $13 - 15.
- The clinical stage biopharmaceutical firm is developing a small molecule for the acute treatment of migraine headaches. Lasmiditan, currently in Phase 3 development in an oral tablet form, is a 5-HT1F receptor agonist that blocks the pain transmission without the side effects of the class of migraine therapies called triptans. The 5-HT1F receptor is a serotonin subtype that lacks the vasoconstrictive properties of other serotonin receptors, which can cause adverse cardiac events in patients with cardiovascular or cerebrovascular disease. Top-line data from a Phase 3 study, called SAMURAI, is expected in Q3 2016. A second Phase 3 evaluating an IV formulation of lasmiditan should commence in H1 2016.
- The company licensed lasmiditan from Eli Lilly.
- 2014 financials ($M): Operating expenses: 2.3 (+43.8%); Net Loss: (3.0) (-34.6%); CF Ops: (0.8) (+49.3%).
- Migraine-related tickers: (OFIX +0.4%)(TEVA +1.8%)(AVNR)(RDHL +0.5%)(PTX -3%)(ALDR -0.8%)(ENDP -0.8%)(JNJ +0.6%)(AMGN -0.7%)(DEPO +1.2%)(AGN)
Yesterday, 12:57 PM
- Privately-held French biotech medDay Pharmaceuticals reports results from a Phase 3 clinical trial (MS-SPI) evaluating MD1003, a pharmaceutical-grade biotin, for the treatment of primary and secondary progressive multiple sclerosis. The study met its primary endpoint in the intent-to-treat population with 12.6% of patients treated with MD1003 showing an improvement in EDSS (Expanded Disability Status Scale) or TW25 (a timed 25-foot walk) at Month 9 compared to 0% for placebo (p=0.0051).
- Secondary analyses showed evidence of a decrease in the risk of disease progression. Mean EDSS scores in the treatment group between the start of treatment and Month 12 decreased (-0.03) compared to progression (+0.13) in the placebo cohort (p=0.015). Four percent of patients in the MD1003 group showed EDSS progression at Month 9 confirmed at Month 12 compared to 13% for placebo (p=0.07).
- Biotin is a B-vitamin known as vitamin H or coenzyme R. It plays a key role in cell growth, the production of fatty acids and the metabolism of fats and amino acids.
- The data were presented at the American Academy of Neurology Annual Meeting in Washington, DC. Full results will be submitted for publication in a peer-reviewed journal.
- MS-related tickers: (BIIB -5.9%)(SNY +0.3%)(NVS -0.9%)(TEVA +1.4%)(FWP -0.3%)(OPXA)(RCPT +0.1%)(CHRS -3.3%)(ABBV +1.7%)
Wed, Apr. 22, 9:47 AM
Wed, Apr. 22, 3:01 AM
- Some of the top investors at Mylan (NASDAQ:MYL), including hedge fund Paulson & Co, are encouraging its board of directors to consider a takeover proposal from Teva Pharmaceutical (NYSE:TEVA), Reuters reports.
- Yesterday, Teva unveiled an unsolicited $40B takeover proposal for the Pennsylvania-based company, saying the acquisition would create an entity with more than $30B in annual revenue, add to earnings in the first year and generate $2B in annual savings.
- Previously: Teva proposes to acquire Mylan for $82/share in cash and stock (Apr. 21 2015)
Tue, Apr. 21, 8:48 AM
- 50% stock and 50% cash
- The proposal gives Mylan (NASDAQ:MYL) shareholders a 37.7% premium to the stock price of Mylan on April 7, 2015, the last day of trading prior to Mylan's press release regarding its unsolicited proposal for Perrigo (NYSE:PRGO), and a 48.3% premium to the unaffected stock price of Mylan on March 10, 2015, which is the last day of trading prior to widespread speculation of a transaction between Teva (NYSE:TEVA) and Mylan.
- Expected to be significantly accretive to Teva non-GAAP EPS, starting in the mid-teens in year 1 and approaching 30% by year 3.
- Teva/Mylan product offerings would create a combined pipeline of over 400 pending ANDAs and over 80 first-to-files in the U.S.
- MYL +9.3% premarket to $74.40. TEVA +2.8% premarket.
- Source: Press Release
- Previously: Bloomberg: Teva offer for Mylan could come today (Apr. 21)
- Previously: Mylan says rumored Teva marriage would not makes sense (Apr. 20)
- Related: Why Does Mylan Want To Buy Perrigo? (Apr. 9)
Tue, Apr. 21, 6:17 AM
- Teva (NYSE:TEVA) could make an unsolicited offer for rival Mylan (NASDAQ:MYL) as soon as today, Bloomberg reports, in what could be the drug industry's largest takeover attempt this year. Mylan has a market value of $33.3B.
- Teva has been working with Barclays on the approach and has contacted other banks about financing a potential deal.
- On Friday, Mylan said it's not interested in a sale and doesn't expect a potential combination to clear antitrust hurdles.
- TEVA +3.9%; MYL +12% premarket
- Previously: Mylan says rumored Teva marriage would not makes sense (Apr. 20 2015)
- Previously: Teva reportedly weighing bid for Mylan; shares jump (Apr. 17 2015)
Mon, Apr. 20, 11:39 AM
- In the largest settlement of its kind ever, Teva Pharmaceutical Industries (TEVA -2.3%) agrees to pay $512M to settle a class action suit filed by drug wholesalers and retailers claiming that Cephalon, which Teva acquired in 2011, used anti-competitive settlements to delay generic versions of its wakefulness drug Provigil (modafinil). Drug buyers filed the lawsuit in 2006. They asserted that Cephalon settled patent suits with Teva, Mylan and Ranbaxy Labs to keep generic versions of Provigil off the market until 2012, violating antitrust law.
- The U.S. Federal Trade Commission sued Cephalon over the settlements in 2008. A bench trial is scheduled to start in June.
Mon, Apr. 20, 11:20 AM
- Generics firm Mylan (MYL -2.9%) admits that it considered a merger with Teva Pharmaceuticals Industries (TEVA -1.4%) but such a deal would be "without sound industrial logic." CEO Robert Coury says, "We believe that it is unlikely that any such combination could obtain antitrust regulatory clearances. Mylan is fully committed to its stand-alone strategy, including its proposal to acquire Perrigo, and today's speculation has no impact whatsoever on this strategy."
- Many observers believe that Mylan's unsolicited $29B bid for Perrigo (PRGO -0.7%) was a defensive tactic to make itself less attractive to Teva.
- Teva has not disclosed its intentions as of yet.
- Previously: Teva reportedly weighing bid for Mylan; shares jump (April 17)
Fri, Apr. 17, 2:30 PM
- The WSJ and Bloomberg report Teva (TEVA +3.4%) is weighing a bid to acquire fellow generic drug giant Mylan (MYL +5.5%), while adding no decision has been made yet. Shaes of both companies have spiked higher.
- Bloomberg's sources state Teva "hasn't made a formal approach yet," though Mylan is aware of Teva's interest. Many analysts have long expected Teva to go after Mylan, given many perceived top and bottom-line synergies. Teva is currently worth $66.2B, and Mylan $34.3B.
- Perrigo (PRGO -2.8%), which Mylan announced a $28.9B ($205/share) bid for last week, has moved lower on the news.
Thu, Apr. 16, 1:07 PM
- The FDA approves Sandoz's (NVS -0.1%) Abbreviated New Drug Application (ANDA) for once-daily Glatopa (glatiramer acetate) injection 20 mg/mL, a generic equivalent to Teva Pharmaceutical Industries' (TEVA -2.9%) Copaxone for the treatment of relapsing forms of multiple sclerosis.
- Glatopa, the first approved substitutable generic to Teva's top seller, was developed under a collaboration between Sandoz and Momenta Pharmaceuticals (MNTA +13.5%). Under the terms of the collaboration agreement, Momenta is eligible to receive up to $140M in milestones, including $10M upon the approval of the ANDA and $10M upon the first commercial sale.
- Copaxone generated $4.2B in sales for Teva the past four quarters, accounting for 21% of its revenues.
Tue, Apr. 14, 9:32 AM
- The FDA accepts for review the New Drug Application (NDA) from Eagle Pharmaceuticals (NASDAQ:EGRX) for Orphan Drug-designated rapid infusion bendamustine HCl for the treatment of patients with chronic lymphocytic leukemia (CLL) or indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or with six months of treatment with rituximab (Rituxan) or a rituximab-containing regimen.
- Clinical studies showed that rapid infusion bendamustine HCl can be administered in 10 minutes in a low-volume 50 mL admixture compared to traditional infusion times of 30 minutes (CLL) to 60 minutes (NHL).
- Teva Pharmaceutical Industries (NYSE:TEVA) will commercialize the product in the U.S. The PDUFA date goal is December.
Wed, Apr. 8, 11:47 AM
- Mylan (MYL +10.4%) submits a non-binding proposal to Perrigo (PRGO +27.6%) to acquire it for $205 per share in a cash-and-stock deal. If consummated, the combined company would generate over $15B in annual sales.
- Generic drug-related tickers: (LCI +3%)(AKRX +4.4%)(MNK +2.8%)(IPXL +2.3%)(TARO +2.3%)(TEVA +3.2%)
Thu, Apr. 2, 10:09 AM
- The first patient has been enrolled in a Phase 2b clinical trial evaluating topically applied TV-45070 (4% and 8% w/w Ointment) for the treatment of postherpetic neuralgia (PHN). TV-45070 is a small molecule sodium channel inhibitor with broad application in nociceptive (sharp) pain.
- PNH is a painful complication of herpes zoster (shingles) in which pain persists for more than three months after the rash disappears. It affects ~20% of people living with herpes zoster, but increases with age. As many as 50% of PHN patients fail to respond to treatment.
- TV-45070 was initially developed by Xenon Pharmaceuticals (XENE -2.1%). Teva Pharmaceutical Industries (TEVA +1.3%) has exclusive global rights to the product candidate via a collaborative development and license agreement established in 2012. Teva is currently conducting a Phase 2b study of TV-45070 in osteoarthritis of the knee.
Wed, Apr. 1, 8:30 AM
- The FDA approves Teva Pharmaceutical Industries' (NYSE:TEVA) ProAir RespiClick (albuterol sulfate) inhalation powder for the treatment or prevention of bronchospasm in patients at least 12 years old with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm in patients at least 12 years old. It will be commercially available this quarter.
- ProAir RespiClick is a breath-actuated, dry powder rescue inhaler for the treatment of acute asthma symptoms. It eliminates the need for hand-breath coordination during inhalation.
Tue, Mar. 31, 12:56 PM
- Oppenheimer upgrades Teva Pharmaceutical Industries (TEVA +1.1%) from Perform to Outperform and raises its price target to $77 (22% upside) citing more M&A deals to come.
- Piper Jaffray upgrades Horizon Pharma (HZNP +1%) from Neutral to Overweight with a price target of $31 (19% upside) due, no doubt, to its recent take out of Hyperion Therapeutics (HPTX -0.3%).
Tue, Mar. 31, 10:09 AM
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