Fri, May 29, 9:09 AM
- Teva Pharmaceutical Industries (NYSE:TEVA) launches its generic equivalent of the oral contraceptive Lomedia 24 Fe (norethindrone acetate and ethinyl estradiol tablets, 1 mg/20 mcg and ferrous fumarate tablets, 75 mg) in the U.S. under the brand name Junel Fe 24 (norethindrone acetate and ethinyl estradiol tablets USP and ferrous fumarate tablets).
- Per IMS data, Lomedia 25 Fe generated ~$32M in sales in the U.S. last year.
Thu, May 28, 2:00 PM
- The U.S. Federal Trade Commission orders Teva Pharmaceutical Industries (TEVA +0.7%) to pay a $1.2B penalty as restitution for its pay-to-delay deals with generic drug makers to postpone launching competitive offerings to Teva's Provigil (modafinil). "This is the largest settlement in FTC history for this type of case," says agency Chairperson Edith Ramirez.
- The fine is on top of the $512M that the company agreed to pay in April to settle a class-action lawsuit.
- The action should substantially dampen or even wipe out these types of deals, commonplace in the pharma business for years.
- Previously: Teva close to $1B settlement over pay-to-delay deals (May 28)
Thu, May 28, 8:55 AM
- Sources close to the situation say that Teva Pharmaceutical Industries (NYSE:TEVA) is nearing closure of an agreement to pay $1B to settle allegations in the U.S. that its Cephalon unit paid drug makers to delay the launch of generic versions of Provigil (modafinil). The deal will include the private settlements already agreed to including $512M to settle a class-action lawsuit that was reached in April.
Tue, May 26, 9:21 AM
- The FDA approves privately-held Boehringer Ingelheim's once-daily Stiolto Respimat (tiotropium bromide and olodaterol) Inhalation Spray for the maintenance treatment of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is not cleared for the treatment of asthma or acute deterioration of COPD.
- Tiotropium, a long-acting anticholinergic, is the active ingredient in Spiriva, the most prescribed COPD maintenance treatment worldwide. Olodaterol, a long-acting beta2-agonist that complements the efficacy of Spiriva, has a fast onset of action that improves airflow in five minutes after dosing.
- COPD-related tickers: (NASDAQ:TBPH) (NYSE:GSK) (NASDAQ:THRX) (NYSE:AZN) (NYSE:NVS) (NASDAQ:REGN) (NYSE:SNY) (NYSE:TEVA) (OTCQX:RHHBY) (NASDAQ:AQXP)
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| 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| 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| 2 Comments
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.
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