legal is gone, hence, delays in getting approvals, drug going, what's next
For almost two years, we, along with our Prevision Policy analysts, have been highlighting the importance of antibiotic drug development.
Despite increasing interest in antibiotics, the sales potential of these products is still not fully reflected in the valuations of key players in the space (Actavis (ticker: ACT ), Tetraphase Pharmaceuticals ( TTPH ), Medicines ( MDCO ), Cempra ( CEMP ), Paratek Pharmaceuticals ( PRTK ), Merck ( MRK ), Achaogen ( AKAO ) and Theravance Biopharma ( TBPH )).
At current rates of resistance, government studies estimate 10 million deaths annually from infections by 2050. This would make antibiotic resistance the leading cause of death world-wide, higher than cancer, heart disease and diabetes. So the need for more effective antibiotics is not just hype, it’s hyper-serious. Annual deaths from antibiotic resistance claimed 2.5 times more lives than those during the Ebola outbreak.
The world-wide antibiotics market is about $26 billion, and we expect U.S. launches to increase sales to $40 billion by 2020, which is a 9%, five-year compounded annual growth rate (CAGR) (Europe and the rest-of-the-world would be potential upside).
We expect the main growth drivers to be: 1) approval and launch of the first wave of new gram positive and gram negative antibiotics; 2) higher pricing for next-generation antibiotics, which is supported by the government and payors; and 3) development of the next wave of antibiotic drugs, focused on limited-population antibiotics, which could command oncology and rare-disease-level pricing, community-based antibiotics and new classes of antibiotics (versus improvement of existing classes).
Legislative and regulatory changes have brought pharma companies, including large pharma, back into the antibiotic industry, after a void of development since the 1980s. We would highlight four key incentives here: 1) Generating Antibiotic Incentives Now (the GAIN Act) gives qualified intellectual disabilities professionals (QIDPs) an additional five years of exclusivity, priority review, and Fast Track; 2) Antibiotic Development to Advance Patient Treatment Act of 2013 (the ADAPT Act) gives an alternate approval path for limited population antibiotics; 3) Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (the DISARM Act) gives better reimbursement for approvals after Jan. 1 -- Merck and Cubist Pharmaceuticals’ ( CBST) Zerbaxa does not qualify (approved in 2014); and 4) GAIN amendment would allow QIDP sponsors to transfer one year of exclusivity to companies in any area.
Since 2013, there has been increasing consolidation in the antibiotics industry with Cubist, Actavis and Medicines acquiring assets. This was followed by the most notable deal, which was Merck’s acquisition of Cubist for $9.5 billion (or nine times enterprise value-to-sales) in 2014. We expect the acquisition of antibiotic drug companies to continue as more large and larger pharma companies look to gain and expand their foothold in a growing therapeutic area.
Pfizer ( PFE ), GlaxoSmithKline ( GSK ), Bristol-Myers Squibb ( BMY ), Lilly ( LLY ) Bayer [of Germany] and Roche [of Switzerland] have or have had antibiotic franchises and drugs. Also, none of the approved or development-stage gram negative drugs effectively covers all three of the hardest-to-treat bacteria: multidrug resistant (MDR) Pseudomonas; extended-spectrum beta lactamase Klebsiella; and Acinetobacter, which means companies with effective gram negative antibiotics (Actavis, Merck, Tetraphase and Medicines) could still fill holes in their coverage spectrum.