FDA approval of Teflaro puts Allergan’s portfolio of anti-infectives into focus

By Steve Brachmann
June 19, 2016

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Allergan, Plc (NYSE:AGN) is a major global developer of pharmaceutical medications and treatments with corporate headquarters in both Dublin, Ireland and Parsippany-Troy Hills, NJ. This April, a proposed merger that would have brought Allergan under the same roof as New York City-based pharmaceutical giant Pfizer, Inc. (NYSE:PFE) was scuttled due to Pfizer concerns that the U.S. Treasury might issue new rules on tax inversion deals which would make it more difficult for U.S. companies to move their tax obligations overseas; Allergan’s Ireland headquarters would have afforded Pfizer this opportunity.

Despite the failed Pfizer merger, Allergan continues to push ahead on the planned sale of its generic pharmaceutical business to Israel-based Teva Pharmaceuticals (NYSE:TEVA) in a deal worth a reported $40.5 billion. Comments reported in early May from Allergan executives credit the research and development focus of the company for maintaining a focus on its drug pipeline which they believe will help stabilize the company in spite of recent turbulence. During 2015, Allergan spent about $1.7 billion on research and development initiatives to develop products from primary care and specialty markets.

Treatments for infectious diseases is one area where Allergan is looking to buoy its fortunes in the coming years. The first quarter of 2016 was a strong one for Allergan, which saw its overall revenues increase by 48 percent when compared to 2015’s first quarter; revenue for Allergan’s branded pharmaceutical divisions grew by 71 percent year-over-year. The company’s infectious disease division was not its most profitable and yet it saw the greatest amount of growth compared to the previous year. The 23 percent growth seen in Allergan’s infectious disease initiatives led to first quarter revenues of $52 million in that division.

At the end of May, Allergan received approval from the U.S. Food and Drug Administration (FDA) for a new anti-infective developed for pediatric patients between the ages of two months up to 18 years old. The newly approved drug is marketed under the brand name Teflaro (ceftaroline fosamil) and is to be prescribed to pediatric patients suffering from acute bacterial skin and skin structure infections (ABSSSI); these infections can include methicillin-resistant Staphylococcus aureus (MRSA) and community-acquired bacterial pneumonia (CABP). In clinical trials, Teflaro achieved a high rate of clinical response and also exhibited a tolerable safety profile.

Teflaro entered the Allergan portfolio thanks to a series of acquisitions in the biopharma realm over the past few years. The pediatric anti-infective was first developed by Forest Laboratories, formerly of New York City, which was acquired by Actavis in February 2014 for a combination of cash and equity which reached a reported $25 billion. Actavis then acquired Allergan, Inc. last March in another cash and equity deal, this one reaching as high as $70.5 billion. In the months after that merger, Actavis changed its corporate name to Allergan although it kept the Actavis brand name for the sale of generic pharmaceuticals in the United States and Canada.

ABSSSI is a blanket term for a range of infections that can affect the skin and skin structures of a person. ABSSSI can arise from burn infections, wound infections, major cutaneous abscesses and extensive cellulitis or erysipelas. Most cases of ABSSSI involve either purulent drainage or pus collection at the site of infection along with redness or edema affecting a region of skin which is greater than 75 cm2. Both Gram-negative and Gram-positive bacteria can cause cases of ABSSSI. Increased resistance to antimicrobials such as methicillin has the FDA and others concerned that new treatments must be developed in order to combat future generations of these infections. The U.S. Department of Health and Human Services (HHS) estimated the fatality rate due to ABSSSI to be 0.61 per 100,000 Americans, or 1,868 fatalities during 2008.

Of much greater concern is the infectious disease known as MRSA, a rare form of staph infection which is related to 11,285 deaths per year as of 2011, according to statistics published by the Centers for Disease Control and Prevention (CDC). In 2011, there were a total of 80,000 MRSA infections according to the CDC. However, prevalence rates for this infection have been dropping; between 2005 and 2011, the overall rate of invasive MRSA infection dropped by 31 percent.

Community-acquired pneumonia, or CABP, is of particular concern especially in hospital environments but also in other places where high levels of public interaction can spread infection. Pneumonia is actually the most common healthcare-associated infection (HAI), with an estimated 157,500 cases occurring in American acute care hospitals during 2011. Although a variety of bacterial strains can cause CABP, the most common cause of infection stems from Streptococcus pneumoniae. As of 2010, the economic burden posed by cases of CABP in the United States approached $17 billion per year.

Allergan’s portfolio of anti-infective agents has been getting a fair amount of notice in the biopharma realm over the past year. The company’s anti-infective portfolio has been showcased in dozens of abstracts exhibited last year at the international medical conference IDWeek as well as last September’s Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC). Most recently, Allergan announced in April that its anti-infective portfolio will be featured in 20 abstracts exhibited at the recent European Congress of Clinical Microbiology and Infectious Diseases (ECCMID).

One of Allergan’s anti-infective treatments which it has been showcasing at recent conferences is Avycaz, a combination treatment involving ceftazidime and avibactam. Avycaz is prescribed to patients suffering from complicated intra-abdominal infections and urinary tract infections, including the bacterial infection of the kidneys known as pyelonephritis. This treatment targets infections caused by a wide spectrum of microorganisms such as E. coli, Klebsiella pneumoniae, Enterobacter cloacae and Proteus mirabilis. A dosage of 2.5 grams is administered to patients intravenously every eight hours in most prescriptions, although the treatment can be adjusted for those patients suffering from renal impairment. The FDA first approved the drug for patient treatments last February; the agency had previously designated the pharmaceutical treatment as a Qualified Infectious Disease Product (QIDP), a recognition of a drug’s efficacy against disease which helps to expedite the drug approval process.

Another Allergan anti-infective, and the first to be approved after receiving the FDA’s QDIP designation, is Dalvance (dalbavancin). Approved by the FDA in May 2014, Dalvance is another treatment for ABSSSI, especially those caused by Gram-positive microorganisms including strains of Staphylococcus and Streptococcus bacteria. Dalvance is also administered intravenously beginning at dosage levels of 1,500 mg over a half hour and reduced to 500 mg dosages in later applications. This dosage level is again adjusted for patients with renal impairment.

Major pharmaceutical companies had largely abandoned the anti-infectives and antibiotics markets during the 2000s but a number of them are seeing the value in pursuing new pharmaceuticals in this field. Between 2010 and 2012, only one antibiotic treatment received approval from the FDA according to reports from The Wall Street Journal. However, that WSJ piece also noted increased hires and activity in infectious disease treatments among many companies which had shuttered those operations, including Swiss pharmaceutical maker Roche Holding (VTX:ROG), UK-based GlaxoSmithKline (NYSE:GSK), British-Swedish multinational AstraZeneca (NYSE:AZN) and Novartis AG (NYSE:NVS), also of Switzerland. According to the technology market research firm BCC Research, the global market for infectious disease treatments, vaccines and diagnostics is expected to grow at a compound annual growth rate of 7.7 percent between 2016, when the market was expected to reach $126.2 billion, through 2021, when the firm expects that market to eclipse $183 billion.

The Author

Steve Brachmann

Steve Brachmann is a writer located in Buffalo, New York. He has worked professionally as a freelancer for more than a decade. He has become a regular contributor to IPWatchdog.com, writing about technology, innovation and is the primary author of the Companies We Follow series. His work has been published by The Buffalo News, The Hamburg Sun, USAToday.com, Chron.com, Motley Fool and OpenLettersMonthly.com. Steve also provides website copy and documents for various business clients.

Warning & Disclaimer: The pages, articles and comments on IPWatchdog.com do not constitute legal advice, nor do they create any attorney-client relationship. The articles published express the personal opinion and views of the author and should not be attributed to the author’s employer, clients or the sponsors of IPWatchdog.com. Read more.

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