A recent article from Bloomberg noted that “as shortages of sterile injectables persist, the makeup of that part of the industry is in flux.” To address the current marketplace struggles, Mylan has agreed to buy Agila Specialties, the injectables unit of Strides Arcolab, for $1.6 billion, and analysts think Claris Lifesciences could be next, saying “it is a matter of supply and demand.”
Claris has five (5) FDA-sanctioned manufacturing facilities in Ahmedabad, and an analyst tells Bloomberg it might be worth about $500 million. Claris has “a ready-made facility,” Ranjit Kapadia, an analyst at Centrum Broking in Mumbai, said in a telephone interview. “There’s a scarcity of injectable facilities in the global space, and in the U.S. there’s a shortage of injectable products, so this may lead to an acquisition.”
Claris was itself barred from selling its products in the U.S. after the FDA found it was producing contaminated drugs and failed to fully investigate the cause, according to a 2010 warning letter from the agency. Claris was told in August 2012 that it had addressed the complaints and was allowed to resume U.S. sales. Last month, it got FDA approval for its ninth drug.
There are shortages of sterile injectable drugs in the U.S. and growing demand, but only a limited number of FDA-approved plants to make them. “Manufacturing injectable drugs requires sterile facilities to protect against unwanted contaminants, and the FDA has cracked down on manufacturers that fail to meet its safety requirements,” Bloomberg noted. FDA’s office of manufacturing and product quality sent 22 warning letters in 2012, up from 19 the previous year, according to its website.
Recently, the Food and Drug Administration (FDA) added Pfizer Inc.’s tuberculosis treatment rifampin to its list of drugs in short supply, the latest in a growing number of spottily available TB medications, reported Reuters. The FDA noted in a post on its website on Monday that the injectible antibiotic will be in short supply until the end of June. The cause of the shortage is a manufacturing delay, it said.
Rifampin is one of the most potent and widely used TB drugs, and its shortage comes amid an increased prevalence of the disease around the world, though TB rates in the United States fell to an all-time low last year. In a letter to physicians dated March 18, Pfizer said a number of vials of the medication may not meet the specifications for drug potency, and exhibited a change in color from the expected red powder to brown or black.
The complexity of the manufacturing process means rivals can’t switch quickly to produce medicines that are in short supply, making it difficult to plug shortages, the FDA says on its website. Currently, 241 drugs — most of them injectable medicines — are in short supply, according to a list on the website of the American Society of Health-System Pharmacists.
The largest producer in the U.S., Hospira, continues to struggle to get its plants to full capacity after running into FDA compliance problems. In fact, Hospira recently disclosed an FDA inspection of its Rocky Mount, N.C., facility, saying 5 agency inspectors reviewed the facility for 3 weeks and issued a Form 483 warning flagging 20 problems at the plant. As a result of the inspection, Hospira recalled the lots of 5 different products, including three lots of propofol injectable emulsion after reports came to light that some vials had visible particles embedded in the glass. These were found in some retained samples.
It also recalled one lot of preservative-free morphine sulfate injection after a customer found either a loose crimp or no crimp on the flip-top vial, which raises the possibility of contamination. It also recalled three lots of diazepam injection, furosemide injection and Quelicin (succinylcholine chloride) injection for the same problem with loose crimping in flip tops. The company said all of the recalls are voluntary and there have been no reports of patients being affected by any of the recalled products, although in each case there is a chance for serious effects.
While companies like Hospira are facing troubles, others such as Hima Pharmaceuticals Plc reported a 19 percent rise in full-year profit, helped by strong growth in its lucrative injectables business, which has drawn interest from several bidders, according to Reuters.
The company, founded in 1978 in Jordan, said it expected overall revenue to increase 10 percent in 2013, with revenue in the injectables business expected to grow in the low double-digits. Revenue in the injectables business rose 49 percent to $470 million, driven mainly by an 83 percent increase in sales in the United States.
Hikma’s injectables business, the second-biggest supplier of generic injectables in the United States, has been able to take advantage of a drug shortage there as several generic drugmakers have been forced to cut capacity in the face of stringent regulatory scrutiny due to quality issues. Hikma said earlier this month it was reviewing options for the injectables business after getting several expressions of interest at a time when M&A activity in injectables is heating up.
Other Drug Shortage News
In other news, FDA updated that EMD Serono’s Cetrorelix Acetate for Injection is no Longer Experiencing Shortages as of March 26, 2013. Additionally, Otsuka recently filed a desperately-needed treatment for resistant strains of TB, but reports of further shortages with one of the current mainstay therapies. Otsuka says it has now filed delamanid as a treatment for multi-drug resistant (MDR) pulmonary TB in patients who are also being treated with a background regimen of anti-TB drugs.
FDA also recently announced that it has fast-tracked and approved Cook Pharmica’s manufacturing facility without doing a preapproval inspection so that it could begin producing a drug that is on the FDA shortage list, reported FiercePharmaManufacturing. he company did not say which drug it was or who it is manufacturing it for, but indicated it was a sterile injectable product. We previously noted that FDA took a similar action to approve a generic version of Johnson & Johnsons cancer drug Doxil from India’s Sun Pharma that it had put through a fast-track approval process.
Finally, International Pharmaceutical Quality (IPQ) recently reported that “The Accelerated Recovery Initiative (ARI) – an FDA/industry partnership being coordinated by pharma data manager IMS – is gaining momentum in its effort to forecast, prevent, and mitigate the impact of drug shortages, and a pilot program is now underway.”
At a mid-March supply chain conference in Cincinnati, Ohio cosponsored by Xavier University and FDA, IMS Commercial Effective Services Senior Principle Michael Barnes noted that the pilot program is “in the early stages” and is now “getting to the point at which FDA, IMS and a select number of manufacturers are beginning to test the process.” In his presentation at the FDA/Xavier conference, IMS’ Barnes provided insights into:
- the common complaints from stakeholders on how drug shortages are currently handled
- why drug shortages occur
- the formation, purpose and function of ARI, and
- the ARI pilot and the respective roles being played by FDA, GPhA and IMS