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Jun. 15, 2015, 11:33 AM
- The FDA accepts for review Teva Pharmaceutical Industries' (TEVA -1.4%) Biologics License Application (BLA) for reslizumab, a monoclonal antibody that inhibits interleukin-5 (IL-5), for the treatment of adolescent and adult patients with inadequately controlled eosinophilic asthma. The PDUFA date will be in March 2016.
- IL-5 plays a key role in the activation of inflammatory white blood cells called eosinophils.
Jun. 11, 2015, 6:47 AM
- Teva Pharmaceutical (NYSE:TEVA) has now raised its stake in Mylan (NASDAQ:MYL) to 3%, as part of its effort to acquire its rival, Globes reports.
- Yesterday, Teva bought about 1.3M shares in Mylan for close to $100M and has now paid about $1.1B for a total of 14.9M shares.
- Previously: Reuters: Teva set to raise stake in Mylan (Jun. 03 2015)
Jun. 10, 2015, 2:20 AM
- A Pennsylvania judge has recommended Kirkland & Ellis be prevented from advising Teva Pharmaceutical (NYSE:TEVA) on its attempted takeover of Mylan (NASDAQ:MYL) after the law firm represented Mylan on other matters.
- The report is likely to shake up a bitter, three-way takeover battle. Mylan has rejected Teva's bid in unusually harsh terms and is instead plowing ahead with its own, twice-rejected offer for Perrigo (NYSE:PRGO).
Jun. 9, 2015, 11:54 AM
- Proactiveinvestors' Philip Waller says if AstraZeneca (AZN -1.1%) doesn't get serious it will miss out on an attractive acquisition candidate that would boost its pipeline, something it needs to do if it hopes to achieve its previously announced goal of $45B in revenues by 2023.
- The target is San Diego, CA-based Receptos (RCPT +0.3%), a clinical stage biopharmaceutical firm with two promising drugs in development: RPC1063 for relapsing multiple sclerosis and inflammatory bowel disorders and RPC4046 for eosinophilic esophagitis.
- The company has already approached Receptos about a $200 per share bid but it was rejected as were higher bids of ~$280 per share from (TEVA -0.3%) and Gilead Sciences (GILD +1.2%). Receptos is reportedly holding out for $350 per share which would value it at ~$11B or a 124% premium to its current valuation.
- An AZN spokesperson says, "We wouldn't comment on market rumour or speculation."
Jun. 8, 2015, 3:36 PM
- In yet another letter, Mylan (MYL -0.5%) Executive Chairman Robert Coury wants (TEVA -0.9%) to answer two simple questions: Are you going to make a formal offer for us? If so, are you willing to do whatever the U.S. Federal Trade Commission stipulates to make the deal happen?
- A response letter from Teva will, no doubt, be sent shortly.
Jun. 8, 2015, 1:15 PM
- In a letter to Mylan (MYL -0.6%) Executive Chairman Robert Coury, Teva Pharmaceutical Industries' (TEVA +0.2%) President & CEO Erez Vigodman responds to Mylan's rather negative perceptions about the latter's intent regarding a takeover bid. Teva appears committed to getting a deal done and asserts that Mylan is the one who is holding things up.
- Mylan is on the prowl for generic drug firm Perrigo (PRGO -0.9%), who keeps rejecting its offers, the latest at $34B. Teva made a $40B bid for Mylan in April that Mylan rejected.
Jun. 8, 2015, 7:15 AM
- Concert Pharmaceuticals (NASDAQ:CNCE) receives a payment of $50.2M from Auspex Pharmaceuticals pursuant to a September 2011 patent assignment agreement under which Concert assigned Auspex a U.S. patent application related to deuterium-substituted analogs of pirfenidone. Under the terms of the agreement, Concert became eligible to receive the payment due to a change in control of Auspex, which was acquired by Teva Pharmaceutical Industries (NYSE:TEVA) on May 5.
Jun. 3, 2015, 1:47 AM
- Raising additional legal concerns, Teva Pharmaceutical (NYSE:TEVA) is reportedly looking to purchase more shares in Mylan (NASDAQ:MYL), sources told Reuters.
- Teva last week disclosed a 1.8% stake in Mylan, which blasted the move as breaching U.S. antitrust laws. Companies that acquire stakes worth more than $76.3M in rivals must first obtain regulatory approval.
- The strategy is a sign of Teva's commitment to acquire Mylan, as the latter presses on with its own $34B hostile bid for Perrigo (NYSE:PRGO).
- MYL rose 1% in after-hours trading.
Jun. 2, 2015, 10:57 AM
- Teva Pharmaceutical Industries (TEVA -0.4%) launches its generic equivalent to Shire's (SHPG -1.3%) Intuniv (guanfacine) in the U.S. in four strengths (1 mg, 2mg, 3 mg, 4 mg). It is indicated for the treatment of attention deficit hyperactivity disorder or ADHD.
- According to IMS, sales of Intuniv were ~$800M over the past 4 quarters.
Jun. 2, 2015, 3:29 AM
- Mylan (NASDAQ:MYL) has accused Teva Pharmaceutical (NYSE:TEVA), which made a $40B unsolicited offer for the company in April, of violating U.S. anti-trust rules through its recent purchase of a 1.35% stake in the company.
- Mylan, which is attempting to buy Perrigo (NYSE:PRGO) for $34B, also told Teva to "stop playing games" and either turn its $40B approach into a formal bid or walk away.
- A takeover by Teva would torpedo any Mylan deal with Perrigo.
May 29, 2015, 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.
May 28, 2015, 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)
May 28, 2015, 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.
May 26, 2015, 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)
May 21, 2015, 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%)
May 13, 2015, 10:31 AM| May 13, 2015, 10:31 AM | 1 Comment
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