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Oct. 29, 2015, 9:13 AM| Oct. 29, 2015, 9:13 AM
Oct. 29, 2015, 8:44 AM
- Results from a Phase 2 clinical trial evaluating Revance Therapeutics' (NASDAQ:RVNC) injectable RT002 against placebo and Allergan's (NYSE:AGN) BOTOX Cosmetic showed RT002's superiority in treating glabellar lines (frown lines). The 268-subject study assessed the safety, efficacy and duration of effect for three doses (20, 40 and 60 units) of RT002, a botulinum toxin A drug candidate.
- At week 4, the primary efficacy measurement of at least a one-point improvement in frown lines based on the IGA-FWS scale for all three doses of RT002 was highly statistically significant compared to placebo (p<0.001). All three doses of RT002 achieved a 100% response rate (minimum of one-point improvement in frown lines) at week 4 versus 95% for BOTOX Cosmetic.
- The 40U dose of RT002 was statistically superior to BOTOX Cosmetic on all three responder definitions for the IGS-FSW duration of effect, with a median duration of 23.6 weeks compared to 18.8 weeks for BOTOX Cosmetic (p=0.020).
- At week 16, more than twice as many participants receiving RT002 40U and 60U maintained none or mild wrinkles per the IGA-FWS scale compared to those receiving BOTOX Cosmetic (p=0.002).
- RTOO2 was safe and well-tolerated across all cohorts.
- The company intends to report final results and meet with the FDA in H2 2016. A Phase 3 is expected to commence shortly thereafter. Revance believes the data will support a six-month duration of effect claim.
- Shares are up 58% premarket on robust volume.
Oct. 29, 2015, 6:31 AM
- Allergan (NYSE:AGN) is up 15% premarket on light volume on the news that it is in talks with Pfizer (NYSE:PFE) about a possible merger. If the deal goes through, it would create the world's largest healthcare firm with a market value of $330B, larger than Johnson & Johnson's (NYSE:JNJ) market cap of $278B.
- A lower tax bill is one of the reasons Allergan is an attractive target for Pfizer considering the Botox maker is domiciled in tax-friendly Dublin. The U.S. government clamped down on tax inversion deals last year which scuppered the AbbVie/Shire deal so it is unclear how this might effect Pfizer's ability to change its domicile.
- Potential Pfizer takeover targets GlaxoSmithKline (NYSE:GSK) and Shire (NASDAQ:SHPG) are both down slightly in premarket trading.
- Update: Both Pfizer and Allergan confirm the commencement of "friendly" discussions regarding a potential combination.
Oct. 28, 2015, 8:46 PM
- Pfizer (NYSE:PFE) and Allergan (NYSE:AGN) are considering a combination, Dow Jones is reporting.
- A tie-up between the two would create an entity with more than $300B in market cap, and would be the biggest announced takeover this year.
- Pfizer recently approached Allergan about a deal, sources tell The Wall Street Journal.
- Price could be an obstacle; on Tuesday Pfizer chief Ian Read says he's seen rival stock prices fall, but “I’m not sure there has been a readjustment in what the investors and leaders of those companies believe those companies are worth in a transactional situation.”
- Both companies' stocks are up more than 11.5% YTD.
- Related: Allergan: Hunting Or Being Hunted? (Oct. 22 2015)
Oct. 27, 2015, 7:19 AM
- Allergan (NYSE:AGN) acquires an exclusive license to Ironwood Pharmaceuticals' (NASDAQ:IRWD) CONSTELLA (linaclotide) from Almirall, S.A. Under the terms of the agreement, Allergan has the exclusive right to develop and commercialize the GI drug for the treatment of irritable bowel syndrome with constipation (IBS-C), chronic idiopathic constipation and other gastrointestinal disorders in the EU, Switzerland, Turkey and the Commonwealth of Independent States. Financial terms are not disclosed.
- CONSTELLA is currently cleared in the EU for the treatment of symptoms of moderate-to-severe IBS-C in adults.
- Linaclotide, approved in the EU in 2012, was marketed by Almirall under a license agreement with Ironwood. Almirall marketed the drug in Mexico under a sublicense with Allergan, who is co-developing and co-commercializing it in the U.S. with Ironwood.
- Allergan also reacquires the rights to linaclotide in Mexico from Almirall, where it is marketed under the brand name LINZESS.
Oct. 21, 2015, 1:22 PM| Oct. 21, 2015, 1:22 PM | 66 Comments
Oct. 21, 2015, 12:27 PM
- In a quick response to Valeant's (VRX -27.4%) mess regarding routing business through specialty pharmacies, Allergan (AGN -3.9%) says in a statement that it does not rely on this method for distributing its products. About 3% of the sales of branded products are sold through unaffiliated specialty pharmacies, the majority of which are BOTOX Therapeutic and ZENPEP.
- Its Anda Distribution business is through a traditional pharmaceutical wholesaler with no specialty pharmacy capabilities or licensing.
- Trading in AGN has resumed after a brief halt.
Oct. 19, 2015, 8:57 AM
- Allergan (NYSE:AGN) completes its all-cash acquisition of Orange County, CA-based AqueSys, a clinical stage medical device firm developing ocular implants that reduce intraocular pressure (IOP) associated with glaucoma.
- Previously: Allergan buying ocular implant maker AqueSys for $300M+ (Sept. 3)
Oct. 15, 2015, 1:50 PM
- Results from a 3.5-year extension study showed that long-term treatment with Allergan's (AGN +0.2%) BOTOX (onabotulinumtoxinA) consistently decreased urinary incontinence in female patients with overactive bladder (OAB) symptoms who had an inadequate response to or were intolerant of an anticholinergic medicine. The data were presented at the American Urogynecologic Society Meeting in Seattle.
- A total of 749 female subjects who completed either of two Phase 3 studies elected to enroll in the extension in which they received multiple onabotulinumtoxinA (100 units) treatments. 53% (n=397) completed the study. Most discontinuations were non-treatment-related, reflected in the low rates of adverse events (4.8%) and lack of efficacy (5.3%). Results were analyzed for the overall population and discrete subgroups who received exactly 1,2,3,4,5 or 6 treatments of the 100U dose throughout the study. The co-primary endpoints were the change in urinary incontinence episodes/day at week 12 versus baseline and the change in Treatment Benefit Scale at week 12.
- The reductions in daily urinary incontinence episodes were consistent across all treatments (69.6 - 100%) as were the Incontinence Quality of Life scores (>=2.5 times the minimum important difference of +10 points). The overall median duration of effect was eight months. The most common adverse effect was urinary tract infection.
- The FDA approved BOTOX for the treatment of adults with OAB who have failed to respond to or are intolerant of anticholinergic therapy in January 2013.
Oct. 13, 2015, 4:29 PM
- A Phase 3 clinical trial evaluating Ironwood Pharmaceuticals' (NASDAQ:IRWD) linaclotide at a dose of 72 mcg for the treatment of adults with chronic idiopathic constipation (CIC) met its primary objective of a statistically significant improvement versus placebo on the 12-week Complete Spontaneous Bowel Movements (CSBM) Overall Responder endpoint. In addition, the 72 mcg dose demonstrated statistically significant improvement compared to placebo on the Durable CSBM Overall Responder endpoint, currently being requested by the FDA for Phase 3 CIC studies.
- Linoclotide, marketed under the brand name Linzess, was originally cleared by the FDA in August 2012 for the treatment of CIC at a daily dose of 145 mcg and for the treatment of irritable bowel syndrome with constipation at a daily dose of 290 mcg.
- The company and U.S. commercialization partner Allergan (NYSE:AGN) intend to file a supplemental NDA with the FDA in H1 2016.
- IRWD is up 4% after hours on increased volume.
Oct. 13, 2015, 3:49 PM
- Getting out in front of what should be more bashing of their business models at the Democratic debate tonight, the healthcare names (XLV -1.3%) have about doubled the decline in the S&P 500. Within healthcare, it's the biotechs (IBB -3.1%) and pharmaceuticals (XPH -3.2%) leading the way south.
- Celgene (CELG -3.3%), Biogen (BIIB -3.6%), Amgen (AMGN -3.5%), Allergan (AGN -4.1%), Mylan (MYL -3.6%)
- The biotech heavy Russell 2000 (IWM -1.4%) is feeling the pain as well.
- ETFs: IBB, IYH, XLV, XBI, VHT, PJP, BBH, FBT, HQH, CURE, XPH, HQL, PBE, FXH, RXL, IHE, FHLC, SBIO, PPH, RYH, BBC, THQ, BBP, RXD, LABU, LABD, UBIO, ZBIO
Oct. 9, 2015, 8:04 AM
- The FDA accepts for filing Allergan's (NYSE:AGN) supplemental New Drug Application (sNDA) for single-dose administration (1500 mg) of DALVANCE (dalbavancin) for the treatment of adults with acute bacterial skin and skin structure infections ((ABSSSI)) caused by Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA).
- DALVANCE, originally cleared by the FDA in May 2014, is currently administered in a two-dose regimen of 1000 mg followed by 500 mg one week later.
Oct. 1, 2015, 10:14 AM
- The FDA approves Allergan's (AGN +1%) JUVEDERM ULTRA XC for injection into the lips and perioral area for lip augmentation in adults at least 21 years old. The filler, a smooth gel formulation of the naturally occurring sugar hyaluronic acid, is designed to last up to one year.
- JUVEDERM formulations were first cleared in the U.S. in 2006. JUVEDERM VOLUMA XC was approved in 2013 for the treatment of age-related mid-face volume loss.
Sep. 30, 2015, 12:49 PM
- Bruised and battered biotech investors get some welcome buying today as bargain hunters open their wallets. The iShares Nasdaq Biotech Index Fund (IBB +2%) is up nicely, albeit on average volume.
- Key tickers: (AMGN +1.6%)(BIIB +2.5%)(GILD +1%)(CELG +0.7%)(DEPO +12.4%)(HZNP +8.6%)(NVO +0.7%)(AGN +4.9%)(VRX +6.4%)(REGN +0.9%)(TEVA +2%)(SHPG +2.6%)
Sep. 28, 2015, 5:07 PM
- Revance Therapeutics (NASDAQ:RVNC) initiates a Phase 3 clinical trial assessing the safety and efficacy of RT001, an investigational topical gel, for the treatment of lateral canthal lines or crow's feet. The 450-subject study will evaluate a single bilateral application of the gel in patients with moderate-to-severe crow's feet compared to placebo. Interim results are expected in H1 2016.
- The value proposition of RT001 (Botulinum Toxin Type A) is a more natural-looking improvement in wrinkles and the avoidance of the "frozen face look" associated with injectable toxins.
- Related ticker: (NYSE:AGN)
Sep. 28, 2015, 4:53 PM
- Allergan (NYSE:AGN) says it will begin reporting its Global Generic business as discontinued operations in Q3, ahead of the closing of its deal with (NYSE:TEVA), which is expected to close in Q1 2016.
- Its forecast for H2 for continuing operations (U.S. Brands, U.S. Medical, International Brands and Anda distribution) calls for revenues greater than $8B, non-GAAP EBIT between $3.8B - 4.0B and non-GAAP EPS between $6.25 and 6.65.
- After the TEVA deal closes, the company expects 10% branded revenue per year, non-GAAP gross margins of 77 - 79%; non-GAAP SG&A as a percentage of revenue of 21 - 24% and a non-GAAP tax rate of ~15%.
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