Valeant And Allergan Are Not A Match Made In Heaven
Paul Nouri, CFP
Paul Nouri, CFP
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Graham Osborn • 48 Comments
Graham Osborn • 48 Comments
The Preferred Way To Play The Allergan-Pfizer Break Up
Andrew Walker, CFA • 56 Comments
Andrew Walker, CFA • 56 Comments
Mon, Jul. 25, 12:46 PM
- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of Allergan's (AGN -0.9%) TRUBERZI (eluxadoline) for the treatment of adults with irritable bowel syndrome with diarrhea (IBS-D).
- In two pivotal studies, patients treated with TRUBERZI experienced significant reductions in the two most bothersome IBS-D-related symptoms: abdominal pain and diarrhea, with sustained relief over six months.
- A final decision from the European Commission (EC) usually takes ~60 days.
- If approved, TRUBERZI will join Ironwood Pharmaceuticals' (IRWD -2.1%) CONSTELLA (linaclotide), approved by the EC in June 2013, as the only medications in the EU licensed to treat IBS-D symptoms.
Fri, Jul. 22, 7:30 AM
- A New Jersey district court issues a Markman ruling favoring VIVUS (NASDAQ:VVUS) related to its Qsymia (phentermine and topiramate extended-release) patent infringement litigation against potential generic competitors Actavis (NYSE:AGN) and Teva Pharmaceutical Industries (NYSE:TEVA).
- In a Markman ruling, also known as a claim construction ruling, the court determines the meaning of disputed patent claims at issue in the litigation. In this case, the judge adopted VIVUS' proposed constructions for nine of the 10 patents in dispute. A compromise construction was adopted for the remaining one. The last of VIVUS' patents expires in 2029.
- The next phase with Actavis will be expert discovery. The Teva case remains in fact discovery. No trial date has been set.
- Qsymia, approved by the FDA in July 2012, is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in obese adults.
Thu, Jul. 21, 10:29 AM
- Allergan (AGN -0.3%) unit Watson Laboratories notifies Adamis Pharmaceuticals (ADMP +2.7%) that will terminate its license agreement to commercialize Adamis' Epinephrine Pre-Filled Syringe (PFS) for the emergency treatment of anaphylaxis (life-threatening allergic reaction) in the U.S. The timing of Watson's notice enables it to avoid paying a nonrefundable upfront fee and milestone payment.
- Adamis has struggled to achieve FDA approval of the product. Last month, it received its second Complete Response Letter from the agency due to insufficient human factors and reliability data. The company is working on the issues and expects to refile its New Drug Application (NDA) later this year.
- Read now Adamis Pharmaceuticals: The CRL Post-Mortem
Thu, Jul. 21, 9:46 AM
- Results from a randomized 725-subject Phase 3 study assessing the safety and efficacy of Amgen (AMGN +0.4%) and collaboration partner Allergan's (AGN +0.5%) biosimilar candidate ABP 980 compared with Roche's (OTCQX:RHHBY) Herceptin (trastuzumab) demonstrated ABP 980's non-inferiority (no worse than) to the branded product. The data failed to show, however, that Herceptin was not superior to ABP 980 as measured by the primary endpoint of the difference in the percentage of patients with a pathologic complete response. The prespecified equivalence margin was plus/minus 13% and the observed upper end of the confidence interval was slightly higher at 13.4%. Adverse events were comparable.
- Despite the modest miss, the companies believe the data will be sufficient for regulatory approval.
- Amgen and Allergan are collaborating on the development and commercialization of four oncology biosimilars under an agreement inked in December 2011 between Amgen and Watson Pharmaceuticals. Under the terms of the partnership, Amgen has primary responsibility for development, manufacturing and initial commercialization.
Tue, Jul. 19, 9:58 AM
- The FDA approves the use of Allergan's (AGN -0.6%) NAMZARIC (memantine hydrochloride and donepezil hydrochloride) extended-release capsules in patients with moderate-to-severe Alzheimer's disease (AD) who are currently stabilized on Aricept (donepezil hydrochloride), allowing them to directly start combination therapy.
- NAMZARIC was approved in the U.S. in December 2014 for moderate-to-severe AD patients who are currently taking memantine HCl and donepezil HCl.
- Amantadine HCl and memantine HCl ER/donepezil HCl were discovered by Adamas Pharmaceuticals (ADMS -0.4%). It licensed the exclusive U.S. rights to the combo product to Forest Labs in November 2012. Allergan now owns the rights on the basis of the Actavis merger.
Tue, Jul. 19, 3:28 AM
- Teva Pharmaceutical (NYSE:TEVA) has successfully priced a debt offering for $15B worth of senior notes, maturing between 2018 and 2046, to help fund its acquisition of Allergan's (NYSE:AGN) generic drug business.
- "The strength of the demand, which was multiple times the size of the offering, and the attractive prices, are a testament to Teva's financial strength and strong reputation with investors," declared CFO Eyal Desheh.
Mon, Jul. 18, 9:45 AM
- Allergan (AGN +0.1%) files a de novo application with the FDA seeking approval of its Oculeve Intranasal Tear Neurostimulator, a handheld device that is used to temporarily increase tear production in patients with dry eye disease.
- A de novo classification is an alternate approval pathway for novel low-to-moderate risk devices that have no predicate (previously approved) products. In other words, a 510(k) submission is not possible since the product cannot be compared to one currently on the market and and a full PMA is not required since the product is considered low risk.
Thu, Jul. 14, 5:09 PM
- Thinly traded micro cap Revance Therapeutics (NASDAQ:RVNC) slumps 6% after hours on higher-than-average volume in apparent response to its announcement that it completed its Type B/pre-IND/pre-Phase 3 meeting with the FDA regarding the advancement of RT002 (daxibotulinumtoxinA for injection) for the treatment of glabellar (frown) lines. Clinical trials should commence in H2.
- The Phase 3 program will include two placebo-controlled pivotal studies in the U.S. and Canada. The primary endpoint will be a composite of the proportion of patients who achieve a score of 0 or 1 (none or mild) and a two-point improvement from baseline in glabellar line severity at maximum contraction at week 4. The program will also include a long-term open-label safety study. The prospective timeline appears to have disappointed investors.
- In a Phase 2 trial, RT002 beat Allergan's (NYSE:AGN) BOTOX Cosmetic.
- Previously: Revance's RT002 beats BOTOX in mid-stage study; shares up 58% premarket (Oct. 29, 2015)
Thu, Jul. 14, 6:43 AM
- Teva Pharmaceutical (NYSE:TEVA) will raise between $20B-$25B next week to finance its acquisition of Allergan's (NYSE:AGN) generics business, Globes reports.
- The bond offering is aimed at foreign investors.
- Teva in October said it would sell $22B of bonds, mostly dollars but also euro and pounds, in a number of markets to help fund the deal.
Wed, Jul. 13, 9:11 AM
- Teva's (NYSE:TEVA) corporate presentation this morning has perked up investors. Shares are up 3% premarket on robust volume.
- CEO Erez Vigodman said that there are no more hurdles standing in the way of is acquisition of Actavis Generics (NYSE:AGN). The OK by the SEC is apparently imminent.
- In this morning's call, Mr. Vigodman highlighted the benefits of the transaction, including an expected $1.4B in cost synergies and tax savings by the end of 2019. Other pluses by the end of 2019 are: accretion in non-GAAP EPS of 19%, more than $25B in cumulative free cash flow and a return on invested capital of 9.3%.
- Revenue is expected to increase from 19.7B in 2015 to $26.7B - 27.8B in 2019 (9% CAGR based on the midpoint). EBITDA should grow from 6.6B to $10.7B - 11.5B (14% CAGR). Net income is also expected to deliver a CAGR of 14%($5.42B to $7.5B - 8.1B). CAGR of free cash flow is expected to be 11% ($4.9B to $7.2B - 7.8B).
- Based on recent amendments with Allergan, Teva's net cost of the deal has dropped from $40.1B to $35.1B, reducing its net financing needs to $23B from $27B. It net debt at closing will be $34B instead of $38B. Based on expected free cash flow, Teva sees its net debt dropping to $12.7B by the end of 2019.
- In terms of FY2016 andFY2017, Actavis Generics' contribution to Net Income should be $1.8B and $1.9B, respectively.
- Q2 2016 outlook: non-GAAP EPS of $1.19 - 1.22 on revenues of $4.9B - 5.0B. for 2016: non-GAAP EPS of $5.20 - 5.40 on revenues of $$22.0B - 22.5B.
- 2019 outlook for operating income is $10.0B - 10.8B and CF Ops $8.0B - 8.8B.
Wed, Jul. 13, 7:30 AM
- In a regulatory filing, Allergan (NYSE:AGN) reports that it and (NYSE:TEVA) agreed to extend the outside date of their deal to October 26 from July 26 (this is the date that the closing must occur). On the conference call this morning, management stated that the close is imminent, however.
- Other amendments include increasing the base working capital adjustment by at least $650M (up to $800M under certain circumstances), adding Actonel (authorized generic) and Carafate (authorized generic) to the list of excluded products and a reduction in the cash consideration to be paid by $221M.
Wed, Jul. 13, 12:01 AM
- In a letter to shareholders, Sequoia Fund -- the second-biggest shareholder in Valeant (NYSE:VRX) -- says it exited that position completely by mid-June.
- The Fund notes that after longtime CEO and co-manager Robert Goldfarb retired in March, "new leadership elected to sell our position." Valeant once made up 30% of Sequoia's portfolio; the company "was our largest position to start the year and its 80% decline through June 30 badly penalized our results."
- The Fund also said it exited its position in Idexx Laboratories (NASDAQ:IDXX), "a wonderful stock for us over the past 13 years"; and got out of smaller positions, in Allergan (NYSE:AGN) and Cabela's (NYSE:CAB).
- Meanwhile, it bought Carmax (NYSE:KMX), Chipotle Mexican Grill (NYSE:CMG), Charles Schwab (NYSE:SCHW), and Wells Fargo (NYSE:WFC).
Tue, Jul. 5, 8:00 AM
- Juniper Pharmaceuticals (NASDAQ:JNP) announces that Merck KGaA (OTCPK:MKGAY) has received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for OneCrinone 90 mg (progesterone) for the indication of luteal phase supplementation in assisted reproductive treatment.
- This approval further expands the global Crinone progesterone gel franchise into the world's' third largest pharmaceutical market, giving women and couples struggling with infertility in Japan a new, patient-friendly therapeutic option for luteal phase support
- The market launch should commence later this year.
- Merck KGaA has global rights (ex-U.S.) to Crinone and OneCrinone. Allergan (NYSE:AGN) owns the U.S. rights.
Fri, Jul. 1, 8:47 AM
- Under the Europe's Decentralized Procedure, Allergan's (NYSE:AGN) BELKYRA (deoxycholic acid) receives a positive opinion from the Swedish Medical Products Agency for the use of the product to treat moderate-to-severe fullness associated with submental fat (double chin). Approval and subsequent market launch should happen later this year or early 2017.
- The Decentralized Procedure allows for product approval in one country to apply to others in the EU under mutual recognition. In this case, Sweden is the Reference Member State. The other pathway, the centralized procedure, goes through the European Medicines Agency (new drugs and biologics for human use).
Tue, Jun. 28, 7:26 AM
- The European Commission approves AstraZeneca's (NYSE:AZN) Zavicefta (ceftazidime-avibactam) for the treatment of serious Gram-negative bacterial infections requiring hospitalization. The approval includes intravenous use for adult patients suffering from complicated intra-abdominal infections, complicated urinary tract infections (including pyelonephritis), hospital-acquired pneumonia (including ventilator-associated pneumonia) and treatment of aerobic Gram-negative infections in adult patients who have limited treatment options.
- Zavicefta is a combination antibiotic that contains ceftazidime, a previously approved cephalosporin antibacterial drug and avibactam, a non-beta lactam beta-lactamase inhibitor antibiotic to extend bacterial resistance. The addition of avibactam protects ceftazidime from being broken down by beta-lactamases that are produced by resistant bacteria.
- The product is being co-developed with Allergan (NYSE:AGN), who has commercialization rights in North America (branded as AVYCAZ). AstraZeneca has commercialization rights elsewhere.
Mon, Jun. 27, 7:13 PM
- Australia's Mayne Pharma Group (OTCPK:MAYNF -6.8%) is close to a deal worth about $600M to buy assets from Teva Pharmarceuticals (TEVA -3%), Reuters reports.
- The move is one of a few required of Teva for it to gain FTC approval for a $40B acquisition of Allergan's (NYSE:AGN) generic drugs portfolio. That OK could come as soon as early next month and solidify Teva's position as a generic drugs leader.
- Teva's U.S. asset divestitures would come to about $2B in total, a source said. European divestitures, including a UK/Irish generics business expected to be worth more than $1.3B, should wrap by this fall.
Allergan Plc operates as an investment holding company. It is a global, integrated specialty pharmaceutical company focused on developing, manufacturing and distributing generic, brand, brand generic, over-the-counter and biosimilar products. The company operates through the following segments:... More
Industry: Drug Manufacturers - Other
Country: United States
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