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Yesterday, 1:30 PM
- The USPTO issues a Notice of Allowance to Palatin Technologies (PTN -4.3%) for its Patent Application No. 14/313,258 covering methods of treating female sexual dysfunction utilizing the formulation and dose of bremelanotide used in its ongoing Phase 3 studies and commercialization, once approved. When issued, the patent should be effective until November 2033.
- Top-line results from the Phase 3s are expected in Q3. If successful, a New Drug Application (NDA) will be filed in H1 2017.
- Bremelanotide is a synthetic peptide analog of the naturally occurring hormone alpha-MSH, a melanocortin agonist. The melanocortin system plays a key role in sexual function as well as pigmentation, inflammation and energy homeostasis. Its value proposition versus Valeant Pharmaceuticals' (VRX +0.6%) Addyi (flibanserin) is the avoidance of hypotension and syncope (temporary loss of consciousness) when combined with alcohol.
- In an earlier study, the most common bremelanotide-related adverse events were facial flushing, nausea and headache.
Thu, Feb. 4, 9:18 AM
- The Congressional hearing on excessive price hikes by the pharmaceutical industry, featuring Pharma Bro Martin Shkreli, is now in session. A live stream is available on YouTube.
- Related tickers: (NYSE:VRX)(OTCPK:KBIOQ)
- Update: Mr. Shkreli invoked his 5th Amendment rights and refused to answer questions, even when asked about his Wu-Tang Clan purchase. He was removed from the proceedings.
Thu, Feb. 4, 3:16 AM
- A House committee will listen to testimony from Valeant's (NYSE:VRX) interim CEO Howard Schiller over the rapid increase in drug costs.
- Martin Shkreli, who has likewise been criticized for big price hikes, will also attend the hearing, but is expected to exercise his Fifth Amendment rights and not answer questions.
- Separately, British futures trader Navinder Singh Sarao will head to court to determine whether he will be extradited to the U.S. for causing the 2010 Wall Street "flash crash."
Thu, Jan. 28, 4:53 PM
- Talk about bad timing...At a recent town hall meeting in Iowa featuring Presidential candidate Hillary Clinton, resident Ellen Mayberry handed her a note about her personal experience with the rapid rise in drug prices, hoping that she would read it sometime in the future. To her surprise, Ms. Clinton started reading the note immediately. Her reaction and response doesn't bode well for the Pharma industry.
- The drug Ms. Mayberry takes to treat her migraines happens to be made by Valeant Pharmaceuticals (NYSE:VRX). She has been taking the medication since the early 1980s. The price back then was about $180.00 for 10 vials (10 shots). In December, her refill at her local pharmacy costed a whopping $14,729.99 for 10 vials, which was more than double the $6,469.63 price in June 2014.
- Ms. Clinton, unsurprisingly, was shocked and angry about what she had read and proceeded to read the note to the crowd. She stated that she was "going to go after Valeant Pharmaceuticals" for its price gouging and declared "we are going to stop this (predatory pricing)."
- VRX was down 9% today on below-average volume. We're all looking forward to the company's anticipated press release tomorrow that will attempt to control the damage amidst a market that is in no mood for more bad publicity over price hikes.
Wed, Jan. 27, 3:30 PM
- As if biotech investors need reminding, biotechs (and healthcare stocks) are getting some rude treatment today, the market's foul mood notwithstanding. The Nasdaq Composite Index is down 2.5%,but the SPDR S&P Biotech ETF (XBI -4.7%) almost twice as much. The iShares Nasdaq Biotechnology ETF (IBB -3.5%) is faring a bit better, but still down more than the broad market.
- Only Biogen and Abbott have bucked the trend.
- Sample of tickers: (AMGN -2.5%)(BIIB +5.7%)(CELG -3.9%)(GILD -3.3%)(ALXN -1.2%)(ABT +0.3%)(BMY -1.8%)(MRK -3%)(VRX -4%)(PFE -0.9%)
- ETFs: BIB, BIS, CNCR
Mon, Jan. 25, 10:00 AM
- The FDA accepts for review the Biologics License Application (BLA) submitted by AstraZeneca (AZN +0.8%), in partnership with Valeant Pharmaceuticals (VRX -0.5%), seeking clearance of brodalumab for the treatment of moderate-to-severe plaque psoriasis. The agency's action date (PDUFA) is November 16.
- Valeant has exclusive rights to develop and commercialize brodalumab worldwide, except in Japan and certain other Asian countries where Kyowa Hakko Kirin owns the rights. It acquired the rights after Amgen (AMGN +0.4%) backed out due to the potential adverse side effect increased suicidal thoughts.
- Brodalumab is a human monoclonal antibody that binds to interleukin-17 (IL-17), thus blocking its binding to its receptor and inhibiting inflammatory signaling.
- Previously: Valeant strikes psoriasis-drug deal with AstraZeneca (Sept. 1, 2015)
- Previously: Amgen terminates brodalumab co-development deal with AstraZeneca (May 22, 2015)
Mon, Jan. 25, 7:15 AM
- In a letter to employees, Valeant Pharmaceuticals (NYSE:VRX) chief Michael Person says his hospital stay related his severe pneumonia was longer than anticipated but he on on the road to recovery. He does not know when he will be able to return to work, but looks forward to doing so.
- Mr. Pearson went on medical leave in late December. Board member Howard Schiller is acting CEO in his absence.
- Previously: Valeant chief hospitalized with severe pneumonia (Dec. 27, 2015)
Wed, Jan. 6, 8:48 AM
- While Michael Pearson recuperates from his pneumonia, Valeant Pharmaceuticals' (NYSE:VRX) board member and former CFO Howard Schiller will take the helm as interim CEO. He joined the company in December 2011 after a 24-year career at Goldman Sachs and has served on the board since September 2012.
- Previously: Valeant's Pearson on medical leave of absence; shares off 6% premarket (Dec. 28, 2015)
Tue, Jan. 5, 6:17 PM
- The WSJ reports Valeant (NYSE:VRX) plans to name a new CEO replace Michael Pearson, who remains hospitalized, and that both Valeant's current and former CFOs are candidates. However, it's unclear if the newly-appointed CEO would be a permanent replacement.
- Valeant announced last week Pearson is on a leave of absence as he undergoes treatment for a severe case of pneumonia, and that an office of the CEO has been created.
- VRX -1.9% after hours to $99.00.
- Update (6:36PM ET): Valeant is now down 6.6%.
Dec. 31, 2015, 4:44 PM
- In a 13D filed today, Bill Ackman's Pershing Square discloses that its stake in Valeant Pharmaceuticals (NYSE:VRX) is now 8.5% (29,091,122 shares), down from 9.9% (~34.1M shares). The hedge fund appears to have locked in some losses for the tax year, a tough one by all measures. The fund was down almost 21% through November, by far the worst performance for Mr. Ackman.
Dec. 28, 2015, 9:14 AM
Dec. 28, 2015, 8:24 AM
- Valeant Pharmaceuticals (NYSE:VRX) eases 6% premarket on increased volume in response to the company's announcement that CEO Michael Pearson will be on a medical leave of absence effective immediately as he undergoes treatment for a severe case of pneumonia.
- In Mr. Pearson's absence, the company has created an Office of the Chief Executive Officer, consisting of EVP and General Counsel Robert Chai-Onn, EVP and Company Group Chairman Dr. Ari Kellen and EVP and Chief Financial Officer Robert Rosiello, that will serve on an interim basis.
Dec. 28, 2015, 4:23 AM
- Valeant (NYSE:VRX) CEO Michael Pearson has been discharged from a New Jersey hospital after treatment for "severe" pneumonia, though is still being hospitalized at a different location, Bloomberg reports.
- "Out of respect for Mike's family and their privacy, we will only provide updates when appropriate," company spokeswoman Laurie Little said in an e-mail.
- Previously: Valeant chief hospitalized with severe pneumonia (Dec. 27 2015)
Dec. 27, 2015, 8:18 AM
- Valeant (NYSE:VRX) CEO Michael Pearson has been hospitalized with a "severe case of pneumonia" and is receiving treatment, NYT reports.
- His illness comes as investors turn up pressure on the drugmaker to provide a more detailed plan on how it will grow profits in 2016.
- Valeant also faces scrutiny for its past relationship mail-order pharmacy Philidor, and its drug pricing and distribution policies.
Dec. 22, 2015, 3:49 AM
- Buried in the details of a new 20-year distribution agreement between Valeant Pharmaceuticals (NYSE:VRX) and Walgreens Boots Alliance (NASDAQ:WBA) is a $150M financial hit to Valeant that underscores the unusual nature of the deal (which will see the firm buy back its own drugs from Walgreens and then resell them on consignment to the pharmacy).
- The pact will help Valeant replace a controversial mail-order pharmacy, Philidor, which had close ties to the drug company and used aggressive tactics to win insurance payments.
- Previously: Valeant inks fulfillment deal with Walgreens; shares up 8% premarket (Dec. 15 2015)
Dec. 18, 2015, 12:18 PM
- Biogen (BIIB +0.2%) initiated with Overweight rating and $344 (16% upside) price target by Atlantic Equities.
- CVS Health (CVS -0.1%) initiated with Overweight rating and $110 (16% upside) price target by Barclays.
- Clovis Oncology (CLVS +0.9%) initiated with Buy rating and $50 (48% upside) price target by Janney.
- Relypsa (RLYP +2.6%) initiated with Buy rating and $63 (123% upside) price target by H.C. Wainwright.
- HCA Holdings (HCA -0.2%) initiated with Outperform rating and $75 (16% upside) price target; LifePoint Health (LPNT +0.4%) with an Outperform rating and $79 (13% upside) price target; Tenet Healthcare (THC +1.2%) with a Neutral rating and $33 (18% upside) price target and Universal Health Services (UHS +0.4%) with a Neutral rating and $129 (11% upside) price target by Credit Suisse.
- Amgen (AMGN -0.1%) upgraded to Overweight from Equal Weight by Morgan Stanley. Price target raised to $193 (20% upside) from $160.
- Valeant Pharmaceuticals (VRX -1.8%) downgraded to Neutral from Buy by Mizuho Securities. Price target raised to $130 (19% upside) from $111.
Valeant Pharmaceuticals International Inc is a specialty pharmaceutical and medical device company that develops, manufactures, and markets a range of generic and branded generic pharmaceuticals, over-the-counter products and medical devices.
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