Thu, May 21, 10:58 AM
- Thinly traded nano cap Intellipharmaceutics (IPCI +17.3%) heads north on a 10x surge in volume in response to its announcement that the FDA may not require a Phase 3 study for its abuse-deterrent opioid candidate, Rexista Oxycodone XR, if bioequivalence to Purdue Pharma's Oxycontin is demonstrated. The company believes that its previously completed Phase 1 trials fulfill this criterion.
- The firm intends to file its New Drug Application (NDA) within the next 6 - 12 months. Approval is not guaranteed, however. After reviewing the data, the FDA may still require further studies.
- Rexista Oxycodone XR's formulation deters abuse by instantaneously coagulating and entrapping the drug in a viscous hydrogel when pulverized and hydrated. It is also designed to prevent dose dumping if taken with alcohol.
- Related tickers: (PTIE -1.9%)(DRRX)(COLL +1.9%)(ZGNX)(MNK -0.3%)(ACT +1.1%)(TEVA +1.6%)(ABBV -0.7%)(LCI -0.7%)(ALKS -1%)(EGLT -0.1%)(PFE -0.2%)(ACUR -2.4%)
Wed, May 13, 10:31 AM| Wed, May 13, 10:31 AM | 1 Comment
Tue, May 12, 3:05 AM
- Mylan's (NASDAQ:MYL) Chairman Robert Coury told investors he may sweeten the company's offer for Perrigo (NYSE:PRGO) by adding terms that would reduce the risk to its shareholders.
- Coury laid out scenarios that could play out in the future and had even suggested that a Mylan-Perrigo combination could be an attractive target for Pfizer (NYSE:PFE), sources told Bloomberg.
- Mylan has been attempting to buy Perrigo for $34B (in an unsolicited offer that is expected to turn hostile), while rebuffing a takeover bid from Teva (NYSE:TEVA).
Mon, May 11, 11:29 AM| Mon, May 11, 11:29 AM | 7 Comments
Fri, May 8, 5:23 PM
- Mylan (NASDAQ:MYL) management is meeting privately with top investors this week to gain support for its $34B bid for Perrigo (NYSE:PRGO), which last week rejected MYL's latest offer worth $75 and 2.3 MYL shares per PRGO share, and defend itself from Teva Pharmaceuticals' (NYSE:TEVA) $40B takeover bid.
- WSJ's Ronald Barusch relays a report from a Bernstein analyst who met with MYL executives that suggests MYL “could not be clearer” that it is not working primarily for its shareholders; according to the report, when the Bernstein analyst suggested in determining whether to vote for the PRGO deal that MYL shareholders would need to compare it with the Teva offer, MYL disagreed and said its shareholders needed to choose between PRGO and an uncertain Teva deal two years away.
- MYL management said shareholders will be in a “tough place” and choose the PRGO deal, the analyst report said; WSJ's Barusch says an acknowledgment that a board has put its own shareholders in a "tough place" is surprising.
- MYL argues that Teva is the wrong company to acquire MYL; in fact, Executive Chairman Robert Coury says MYL not only is not willing to sell itself to Teva but would consider buying Teva at some point after completing its offer for PRGO, according to a Reuters report.
Thu, May 7, 5:30 PM
- In a setback for branded drug makers, the California Supreme Court rules that financial payments from makers of patented drugs to competitor firms to delay the commercialization of cheaper generic versions of their branded medicines, called pay-to-delay deals, illegally restrain trade and violate the Cartwright Act, the state's primary antitrust law.
- The court reversed a summary judgement to Bayer (OTCPK:BAYRY) and Barr, whose $398.1M deal blocked the launch of generic versions of the antibiotic Cipro (ciprofoxacin) for almost seven years. It found it was immaterial that the companies' agreement settled patent litigation since antitrust principles prohibit a patentee's purchase of a potential competitor's consent to stay out of the market, even when the patent is likely valid.
- The Court's rule also applies to collusive non-cash settlements. An excerpt from its opinion reads: "courts considering Cartwright Act claims should not let creative variations in the form of consideration result in the purchase of freedom from competition escaping detection."
- The U.S. Federal Trade Commission filed a lawsuit last year against AbbVie (NYSE:ABBV), Abbott Laboratories (NYSE:ABT) and Teva Pharmaceutical Industries (NYSE:TEVA) charging the firms with violating antitrust laws and harming consumers with their pay-to-delay transactions related to AndroGel testosterone replacement therapy.
Thu, Apr. 30, 8:15 AM
- Teva Pharmaceutical Industries (NYSE:TEVA) Q1 results ($M): Total Revenues: 4,982 (-0.4%); Generic Medicine: 2,621 (+9.3%); Specialty Medicine: 1,956 (-7.5%); Net Income: 446 (-40.1%); EPS: 1.36 (+56.3%); CF Ops: 1,354 (+50.8%).
- Key product sales: Copaxone: 924 (-13.6%); Treanda: 157 (-12.8%); Women's Health: 129 (+4.0%); ProAir: 124 (+8.8%); Azilect: 107 (-6.1%); Qvar: 98 (+38.0%); Nuvigil: 85 (-15.8%).
- 2015 Guidance: Non-GAAP EPS: $5.05 - 5.35 from $5.00 - 5.30.
Thu, Apr. 30, 7:05 AM
Wed, Apr. 29, 3:34 PM
- Before the open (consensus views):
- Sanofi (SNY -1%), Revenues of $39B.
- Celgene (CELG -0.1%), EPS of $1.06 on revenues of $2.1B.
- AmerisourceBergen (ABC -1.2%), EPS of $1.19 on revenues of $32.3B.
- Teva Pharmaceutical Ind. (TEVA +1.1%), EPS of $1.25 on revenues of $4.8B.
- Shire plc (SHPG -0.6%), EPS of $2.59 on revenues of $1.5B.
- After the close:
- Gilead Sciences (GILD -1.3%), EPS of $2.32 on revenues of $6.9B.
- Biomarin Pharmaceuticals (BMRN -0.2%), loss per share of ($0.53) on revenues of $203M.
Wed, Apr. 29, 12:03 PM
- Perrigo (PRGO +0.1%) rejects Mylan's (MYL +1.6%) beefed-up offer for the Dublin, Ireland-domiciled firm. The new bid is $75 in cash plus 2.3 shares of MYL stock or ~$244 per PRGO share, based on recent prices. This represents a premium of 28%.
- The company maintains that the offer significantly undervalues the firm, although its rationale that the new offer is mathematically below its first bid of $60 + 2.2 shares of MYL stock is clearly biased since it is based on MYL's price on March 10, before speculators began accumulating shares ($55.31). MYL is trading today at ~$74.
- Previously: Mylan commences formal offer for Perrigo (April 24)
- Related ticker: (TEVA +0.5%)
Tue, Apr. 28, 3:49 PM
- The FDA approves the abbreviated New Drug Applications (ANDAs) from Teva Pharmaceutical Industries (TEVA -0.6%), Alembic Pharmaceuticals and Torrent Pharmaceuticals for generic versions of Otsuka Pharmaceuticals' (OTCPK:OTSKY) blockbuster antidepressant Abilify (aripiprazole). According to IMS Health, Abilify logged almost $8B in U.S. sales in 2014.
- Teva is wasting no time in pursuing the opportunity. It announced the U.S. launch of its generic aripiprazole tablets in six strengths (2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg) today.
Mon, Apr. 27, 3:42 PM
- Teva Pharmaceutical Industries (TEVA -4.3%) is allegedly scheduled to meet with institutional holders of Mylan (MYL -5.5%) this week in an effort to clarify the valuation necessary to close the deal. Some observers think a revised bid will be in the $85 - 95 range. Teva's first offer, which Mylan rejected, was $82.
Mon, Apr. 27, 10:40 AM
- As expected, Mylan's (MYL -3.2%) Board of Directors unanimously rejects the $40.1B offer from Teva Pharmaceutical Industries (TEVA -2.4%) saying it grossly undervalues the company and would require Mylan shareholders to accept "low-quality" TEVA shares in exchange for "high-quality" MYL shares.
- TEVA won't give up easily. Look for a revised bid in the near future.
- Previously: Teva proposes to acquire Mylan for $82/share in cash and stock (April 21)
Mon, Apr. 27, 8:59 AM
- Teva Pharmaceutical Industries (NYSE:TEVA) returns the rights to the investigational prostate and lung cancer candidate, custirsen, to OncoGenex Pharmaceuticals (NASDAQ:OGXI) after it terminated its collaboration that began in 2009. Under the terms of the termination, Teva will pay OncoGenex $23.2M, which is part of a $27M advance reimbursement.
- OncoGenex believes that its current resources plus the Teva payment will be sufficient to complete the Phase 3 AFFINITY trial in prostate cancer through data readout in late 2015/early 2016 and to continue the Phase 3 ENSPIRIT trial in lung cancer through the second interim futility analysis expected mid-year, as well as advance other development programs.
- Custirsen blocks the production of the protein clusterin, which is believed to play a key role in cancer cell survival and treatment resistance.
Fri, Apr. 24, 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)
Fri, Apr. 24, 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%)
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