Allergan and Gedeon Richter Plc. to Present Data on VRAYLAR

Allergan plc and Gedeon Richter Plc. announced they will present data on VRAYLAR (cariprazine) in patients with schizophrenia during the 54^th  American College of Neuropsychopharmacology (ACNP) Annual Meeting.

Data to be presented include additional analyses of cariprazine for the potential treatment of predominant negative symptoms in patients with schizophrenia. Also presented will be data investigating the metabolic safety profile of cariprazine and its impact on long-term schizophrenia relapse prevention.   

VRAYLAR is an oral, once daily atypical antipsychotic approved for the acute treatment of adult patients with manic or mixed episodes associated with bipolar I disorder, with a recommended dose range of 3 to 6 mg/day and for the treatment of schizophrenia in adults, with a recommended dose range of 1.5 to 6 mg/day. The safety and efficacy of VRAYLAR was studied in a clinical trial program of more than 2,700 patients with these conditions.

 Vraylar acts as a partial agonist at the dopamine D₃ and D₂ receptors. At antipsychotic doses, Vraylar shows high brain occupancy of  both D₃ and D₂  receptors in schizophrenia patients. Vraylar is also a high affinity partial agonist at serotonin 5-HT_1A receptors. In addition, Vraylar acts as an antagonist with high affinity at 5-HT_2B receptors and moderate affinity at 5-HT_2A and histamine H₁ receptors . Vraylar shows lower binding affinity to the serotonin 5-HT_2C and α_1A- adrenergic receptors and has no appreciable affinity for cholinergic muscarinic receptors. VRAYLAR was discovered and co-developed by Gedeon Richter Plc and is licensed to Actavis, now Allergan, in the U.S. and Canada.

FDA Approves Three Extended Release Products Equivalent To Mucinex And Mucinex DM

Allergan plc and its partner Perrigo Company plc announced today that Allergan has received U.S. Food and Drug Administration (FDA) approval for its Abbreviated New Drug Applications for three Mucinex® equivalent products.

• Mucinex® DM Regular Strength (guaifenesin 600mg and dextromethorphan 30mg)
• Mucinex® DM Maximum Strength (guaifenesin 1200mg and dextromethorphan 60mg)
• Mucinex® Maximum Strength (guaifenesin 1200mg)

Perrigo will begin shipments of the products to its retail and wholesale customers in the U.S in time for the 2016 cough and cold season. These products will be packaged and marketed as store brands which will give consumers high quality, value alternatives to these Mucinex® extended-release products.

Mucinex® Maximum Strength is an expectorant indicated to relieve chest congestion and thin and loosen mucus.  Sales for the last twelve months were $73 million.  

Mucinex® DM Regular and Maximum Strengths are expectorants indicated to control coughs and thin and loosen mucus.  Mucinex® DM Regular and Maximum Strengths sales for the last twelve months were $67 million and $104 million, respectively.

Allergan changes deal for Kythera to cash

Allergan PLC amended the terms of its pending $2.1 billion deal for double-chin treatment maker Kythera Biopharmaceuticals Inc. by agreeing to pay for it all in cash and dropping the stock component. In a news release Wednesday, the companies expect the all-cash transaction at $75 a share can be completed more quickly than the original deal announced in June, which was comprised of 80% cash and 20% stock.

At the time, Allergan Chief Executive Brent Saunders said the maker of wrinkle-treatment Botox had opted against an all-cash deal to save "fire power for future deals" this year. Since then, Allergan has agreed to sell its generics unit to Teva Pharmaceutical Industries Ltd. in a cash-and-stock deal valued at $40.5 billion, of which $33.75 billion is expected to be in cash.

Allergan and several other health-products companies have been on a deal-making binge in recent years with the help of low interest rates, and to cope with pricing pressures and relatively high U.S. corporate tax rates.

In April, Kythera won U.S. Food and Drug Administration approval for injections given to eliminate the fat that makes double chins. Many doctors had been looking to add the new drug, called Kybella, to their arsenal of cosmetic treatments that include wrinkle-eraser Botox. Allergan is counting on the interest in a new cosmetic treatment to bolster its market-leading cosmetic-medicine portfolio, and help it propel Kybella to sales exceeding Kythera's goals of $500 million in the U.S.

Actavis was renamed Allergan earlier this year, after doing $100 billion in deals last year that gave it brand-name drugs, notably wrinkle fighter Botox. Actavis acquired Allergan in a deal valued at $70.5 billion, the biggest from 2014. The deal ended one of the year's more dramatic takeover battles in which Dublin-based Actavis beat out Valeant Pharmaceuticals International Inc. for Allergan.

Allergan agrees to acquire AqueSys

Allergan PLC said late Thursday it agreed to acquire privately-held AqueSys Inc. for $300 million cash. AqueSys makes medical devices that are placed in the eye to reduce pressure associated with glaucoma. Allergan said that it will also pay milestone payments for regulatory approval and commercialization of AqueSys's XEN45 device, which is expected to get U.S. approval in late 2016 or early 2017. Allergan plans to close the acquisition in the fourth quarter.

Allergan to Acquire AqueSys

Allergan plc a leading global pharmaceutical company, and AqueSys, Inc. a private clinical stage medical device company focused on developing ocular implants that reduce intraocular pressure (IOP) associated with glaucoma, today announced that they have entered into an agreement under which Allergan will acquire AqueSys in an all-cash transaction.  Under the terms of the agreement, Allergan will acquire AqueSys for a $300 million upfront payment and regulatory approval and commercialization milestone payments related to AqueSys' lead development programs, including XEN45. 

The acquisition of AqueSys adds XEN45, a soft shunt that is implanted in the subconjunctival space in  the eye through a minimally invasive procedure with a single use, pre-loaded proprietary injector. The proprietary XEN45 technology facilitates aqueous fluid flow to lower Intra-Ocular Pressure (IOP) while protecting against the potential for hypotony (IOP that is too low) that is associated with current subconjunctival procedures.  The minimally invasive procedure is performed by ophthalmologists.

XEN45 has received a CE mark in the European Union  where it is indicated for the reduction of intraocular pressure in patients with primary open angle glaucoma where previous medical treatments have failed. The CE mark allows treatment in conjunction with a cataract procedure or as a standalone procedure. XEN45 is also approved for use in Turkey, Canada and Switzerland. AqueSys is pursuing reimbursement in these countries.  In the United States, XEN45 is in late-stage development, with the final US Investigational Device Exemption (IDE) clinical trial fully enrolled in the second quarter of 2015.  Final approval by the U.S. Food and Drug Administration is expected by late 2016 or early 2017 via the 510K device pathway.

FDA Approved Updated Label for TEFLARO

Allergan plc announced the U.S. Food and Drug Administration (FDA) has approved the company's supplemental new drug application (sNDA) to update the label for TEFLARO^® (ceftaroline fosamil) for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP). The approved label contains new clinical data from two ABSSSI trials that included patients with baseline Staphylococcus aureus bacteremia. Bacteremia is the presence of bacteria in the bloodstream.  Bacteremia complicates infection treatment and in the most serious cases, can be fatal. 

With this updated label, TEFLARO also is now approved to be administered by intravenous (IV) infusion in five minutes to one hour in adult patients 18 years and older. 

TEFLARO was first approved by the U.S. FDA in October 2010 for the treatment of adults with CABP and ABSSSI due to designated susceptible pathogens.  TEFLARO is a bactericidal cephalosporin with activity against both Gram-positive and Gram-negative pathogens. TEFLARO is indicated for the treatment of CABP, including cases caused by Streptococcus pneumoniae , and ABSSSI, including cases caused by methicillin-resistant Staphylococcus aureus (MRSA). TEFLARO is the first and only cephalosporin with activity against MRSA.  In clinical trials, TEFLARO was generally well-tolerated with an adverse event profile consistent with the cephalosporin class of antibiotics. TEFLARO has been administered in over 2.3 million days of therapy, treating more than 350,000 patients.