Somehow, I found myself at the boarding gate having fast-tracked through security with speed usually reserved for animals of the four-legged variety. Time for a coffee even―especially as one of the runways at Heathrow was closed causing delays to all in- and outbound flights. Not going well.

Nevertheless, I found myself stood in Frankfurt  Messe on October 24 considering my options and hoping I would still be able to make the CPhI pre-show conferences planned for the day before the main events. Success!

I was fortunate enough to attend a conference entitled “The challenges and opportunities in biosimilars and biobetters,” which offered a rare glimpse into the strategies, concerns and successes to be had in this contentious area. Moderated by Alan Sheppard of  IMS Health the conference brought together several schools of thought on the topic, which perhaps mirror the global view. Sheppard classified current thinking on biosimilars under three headings: a mirage, an opportunity with some way to go, and something just around the corner. And taking into account the presentations that followed, perhaps it is a little of all of these things.

Genentech’s (Roche Group) Gautam Ganguly gave an excellent, high level account of some of the current challenges of entering the biosimilar market, the level of uncertainty in the US regulatory framework a notable example. The big question here was “how similar is similar?” and the answer is somewhat unclear and product dependent. Ganguly pointed out that, because of complex manufacturing,  “the process is the product” with each stage conferring unique properties on the resulting biologic making biosimilars very distinct from small molecule generics. Ganguly also noted the companies entering the biosimilars space, making it seem crowded, with traditional innovators, CMOs and generics companies all vying for the same unpredictable market.

Frederico Pollaro from Richter-Helm BioTec posed the question “make or buy?” and provided some case study examples as to his group’s decision-making processes. The key message here was the importance of being aware of the timeline involved and asking if your target biosimilar will still be an attractive option 10 years down the road; new therapies, price erosion and market instability all factors to consider. Pollaro also made clear the opportunity, given the right target, to expand the market and take advantage of potential volume growth.

The final presentation in the conference was delivered by Anjan Selz of Finox Biotech and was, I suspect, inspirational to most. Describing his company as a renegade virtual biotech, Selz wowed delegates with the story of how Finox moved from cell bank to Phase III in just four years, comically noting that “we haven’t made any money yet!” Once again, choosing the target carefully was a key message. For Finox, picking a niche product with lower levels of competition was the route taken; follicle-stimulating hormone (FSH), with its specialised market and motivated, informed patients offered a strong business case further justified by its successful history. Selz said that the key to success was creating a differentiating factor, whether through improved stability, formulation, delivery or branding, because to physicians “FSH is FSH” and the word biosimilar has no meaning.

Tomorrow (today for you), the co-located events of CPhI Worldwide, ICSE, InnoPack and PMEC and a horde of attendees will descend on the Messe―the anticipation (and sawdust) is palpable.

How was the start of the show for you? Let me know in the comments box or give us your opinion in our quick survey. We’ll be publishing some of the responses anonymously in one of upcoming newsletters.

Earlier this month, FDA approved Roch’s Zelboraf (vemurafenib) and companion diagnostic for BRAF mutation-positive metastatic melanoma. Zelboraf is an oral, small-molecule kinase inhibitor indicated for treating patients with unresectable or metastatic melanoma with the BRAF V600E mutation as detected by the cobas 4800 BRAF V600 Mutation Test, a polymerase chain reaction-based diagnostic test developed by Roche. The B-Raf protein is a key component of the Ras-Raf pathway involved in normal cell growth and survival. Mutations that keep the B-Raf protein in an active state may cause excessive signaling in the pathway, leading to uncontrolled cell growth and survival. These mutations of the B-Raf protein are thought to occur in an estimated half of all melanomas and 8% of solid tumors. Zelboraf is being codeveloped under a 2006 license and collaboration agreement between Roche and Plexxikon, a member of the Daiichi Sankyo Group. “The FDA approval of Zelboraf marks a major step forward in personalizing the treatment of metastatic melanoma, a devastating disease that until this year had limited approved treatment options,” said Hal Barron, M.D., chief medical officer and head of global product development at Roche, in a company press release.

Among the pharmaceutical majors, Roche is most active in pursuing a strategy of combining molecular diagnostics with targeted drug development. Such an approach has the potential of developing more clinically efficacious drugs, albeit to a smaller, but better defined patient population, which serves the pharmaceutical side of the business, but also Roche’ molecular diagnostics business. In reporting its 2010 results in February 2011, Roche reported that it had 12 new molecular entities in late-stage development, of which six were potential personalized healthcare medicines with planned companion diagnostic tests. The recently approved Zelboraf and related diagnostic test was one of those six treatments.

Analysts are bullish on Zelboraf as a potential blockbuster due to the drug’s potential in addressing an unmet medical need in treating metastatic melanoma. It will be important to watch the financial results for this newly approved drug and related diagnostic as well as the pipeline progression of Roche’s other personalized medicines to see whether the marriage of targeted therapeutics with related molecular diagnostics may indeed represent a new winning paradigm in drug development.

The issues surrounding the patent-dispute case date back to 1988, when a California-based research company, Cetus, began to collaborate with scientists at Stanford University’s Department of Infectious Diseases to test the efficacy of new AIDS drugs. Mark Holodniy, a research fellow at Stanford at the time, was assigned to Cetus to conduct research and developed a PCR-based procedure for measuring the amount of HIV in a patient’s blood. Upon returning to Stanford, he and other Stanford employees tested the procedure, and Stanford secured three patents relating to the measurement process. Roche later acquired Cetus’s PCR-related assets, and after conducting clinical trials on the HIV quantification method developed at Cetus, commercialized the procedure. In his capacity at Stanford, Holodniy had signed an agreement assigning his interests to the university for inventions that resulted from his employment there and also had signed an agreement with Cetus, as part of gaining access for his research at Cetus, that assigned his interests to Cetus.

The crux of the case centered on whether Holodniy had the right to assign his interest to Cetus or whether the rights belonged to Stanford under the University and Small Business Patent Procedures Act of 1980 (i.e., Bayh-Dole Act), which established a framework for determining ownership interest in federally funded research. Stanford first sued Roche in 2005, and in 2009, a federal appeals court ruled that Stanford did not have grounds for patent infringement. The US Supreme Court ruling this week affirmed the lower court’s decision. Chief Justice John Roberts, who delivered the opinion of the court stated: “The Bayh-Dole Act does not automatically vest title to federally funded inventions in federal contractors or authorize contractors to unilaterally take title to such inventions.”

Although the opinion of the Court involved the specific contractual details of the case, including the timing of the agreements and whether research performed at the time in question was under federal funding, the ruling raises important issues in intellectual property rights, technology transfer, and the role of public and private funding in research, particularly in light of pending US patent reform. In today’s quest for innovation, pharmaceutical-based and other industrial-based research is increasingly reliant on partnerships between academia, the private sector (both large and small companies), and government. The financial interests of the private sector and universities in intellectual-property ownership are clear, but what is more murky is how to best marry those interests in a robust and equitable system of mutual benefit. Although cliched, the term “win–win” should be more than lip service, but something that is put into practice in the design and implementation of research, technology transfer, and the rewards of eventual commercialization. Current patent law or any pending reforms can create a framework, but ultimately, it is the specific parties involved in these academic–industy–government partnerships, which need to recognize and legitimize the symbiotic nature of their common efforts.

Roche seems to think there is promise in the technology. Under its agreement, Roche will guarantee at least $25 million in funding for technology access fees and research and development to Aileron, which is eligible to receive up to $1.1 billion in payments based on discovery, development, regulatory, and commercialization milestones, if drug candidates are developed for five undisclosed drug targets in the following areas: oncology, virology, inflammation, metabolism, and central nervous system.

Aileron’s “stapled peptides” are designed to address pharmacological limitations of small molecules and existing biologics in intracellular protein–protein interactions. Although small molecules are able to penetrate cells, the large binding surfaces for intracellular protein–protein interactions often make small-molecule modulators ineffective. Although peptides and proteins have the size and functionality to effectively modulate intracellular protein–protein interactions, they often do not permeate cells and therefore are used to modulate extracellular targets such as receptors (1). These limitations of small molecules and existing biologics make a vast array of potential drug targets “undruggable.” Approximately 80% of potential drug targets are considered “undruggable” by either modality (1, 2).

So how can these limitations be addressed? The concept of using peptides to modulate intracellular processes is not new, but these strategies have historically failed because peptides lack the ability to enter cells, are inherently unstable within the body, are rapidly broken down into inactive fragments by circulating enzymes such as proteases, and are quickly filtered from the bloodstream by the kidneys. Stapled peptides seek to resolve those problems. Because many “undruggable” therapeutic targets include those protein–protein interactions in which α-helices are required in lock-and-key-type mechanisms, an approach is to design α-helical peptides that have structural and functional properties that enable them to penetrate into the cell, bind to the therapeutic target, and modulate the biological pathway (1). Aileron stabilizes peptides by “stapling” them with hydrocarbon bonds into an α-helix. Once constrained in the α-helix structure, the peptides are protected from degradation by proteases. The stabilized α-helical peptides can penetrate cells by energy-dependent active transport and typically have a higher affinity to large protein surfaces (1, 2).

In advancing stapled peptides, Aileron has brought together scientific and financial weight. Aileron was cofounded in 2005 by Gregory L. Verdine, current chair of Aileron’s scientific advisory board and a chemical biologist at Harvard University, with initial funding from a private investment group. In 2006, the company acquired exclusive rights from Harvard University and the Dana-Farber Cancer Institute to develop and commercialize a drug-discovery pipeline of stapled peptides. In 2006/2007, Aileron licensed rights from the fine-chemicals and technology firm Materia (Pasadena, CA) for catalysts used in olefin metathesis. Materia holds the rights to the olefin metathesis technology developed by Robert H. Grubbs, professor at the California Institute of Technology, who was awarded the Nobel Prize in Chemistry in 2005 with Richard R. Schrock and Yves Chauvin for their work in olefin metathesis using ruthenium-based catalysts. Part of the reaction scope of olefin metathesis is ring-closing metathesis (RCM), which transforms a diene into a cyclic alkene and is used to create macrocycles, including bioactive cyclic peptidomimetics. Grubbs was one of the first to offer research describing RCM to tether residues of helical peptides (3, 4). In 2008, Aileron acquired exclusive rights from New York University for additional methods to stabilize peptides and peptidomimetics. In 2009, Aileron received $40 million in venture capital funding, which included funding from four pharmaceutical venture capital funds: SR One (GlaxoSmithKline’s venture capital fund), the Novartis Venture Fund, Lilly Ventures (Eli Lilly’s venture capital fund), and Roche Venture Fund.

So with a sound scientific basis and financial support from the pharmaceutical majors, it will be interesting to see how stapled-peptides fare. Like their “cousins,” aptamers and peptidomimetics, it has yet to be seen if “the offspring” of the marriage of small-molecules and biologics-based approaches can find a place at the drug-development table.

References
1. T. Sawyer, Chem. Biol. Drug. Des. 73 (1), 3–6 (2009).
2. W. Wolfson, Chem. & Biol. 16 (9), 910–911 (2009).
3. J.B. Binder and R. Raines, Curr. Opin. Chem. Biol. 12 (6), 767–773 (2008).
4. R. Grubbs, Angew. Chem. Int. Ed. 37, 3281–3284 (1998).

In a speech last week to the City Club of San Diego, John Lechleiter, chairman and chief executive officer of Eli Lilly, offered very candid remarks about the state of innovation in the pharmaceutical industry, saying that the engine of biopharmaceutical innovation is “broken.” His comments may be a bitter pill to swallow in light of escalating investment in research and development (R&D), but his frankness may just be the remedy the industry needs to reinvent itself.

“At a time when world desperately needs more new medicines—for everything from H1N1 to Alzheimer’s disease—we are taking too long, spending too much, and producing far too little,” said Lechleiter. “Repowering pharmaceutical innovation is an urgent need not only for our company and our industry but for our nation—and for communities like San Diego and Indianapolis [the headquarters of Eli Lilly] that have a huge stake in the life sciences. We remain dependent on a society that welcomes and values new ideas, and public policy that enables innovation to be rewarded for the value it creates. But we also know that we need to change.”

Lechleiter outlines three major challenges for the industry. These include: a loss of trust in product safety and in the honesty of pharmaceutical businesses, for which he said, “we mostly have ourselves to blame;” a risk-averse policy and regulatory environment that has led to hurdles for new drugs; and the pressure of the healthcare system, where the pharmaceutical industry has become an attractive source for policymakers to seek cost savings, even though prescription-drug spending accounts for only 10% of healthcare spending.

Lechleiter suggested using the three “C’s” for pharmaceutical innovation: collaboration among the large pharmaceutical companies with smaller companies, academia, and government; competency by advancing scientific tools to better understand human biology; and culture by developing a mindset that places patients and improved outcomes at the center of the research process. On a company-specific note, Lechleiter said that Eli Lilly is espousing those philosophies. He points to the company’s fully integrated pharmaceutical network (FIPnet) model as a vehicle for external collaboration; the company’s use of advanced analytics and clinical trial designs; and cultural changes to create a greater focus on the patient.

It is clear that the pharmaceutical industry is at a moment of change. In 2008, the US biopharmaceutical industry spent a record $65.2 billion on R&D, according to a report by the Pharmaceutical Research and Manufacturers of America (PhRMA). At the same time, however, the the level of innovation has not appreciably improved. The average number of new drugs approved in the US (as measured by the number of NMEs and new biologic license applications approved by the US Food and Drug Administration’s Center for Drug Evaluation and Research) between 2005 and 2008 was 21. Moreover, only 2 of 10 marketed drugs ever return revenues that match or exceed R&D costs, according to the PhRMA report.

Some pharmaceutical majors have turned to a proven formula in seeking to improve near-term and long-term results, namely building critical mass through mergers and acquisitions (M&A). Pfizer’s $68-billion acquisition of Wyeth, Merck’s $41-billion pending acquisition of Schering-Plough, and Roche’s $47-billion acquisition of Genentech are three large-scale acquisitions in 2009. What remains to be seen is whether the new R&D structures announced by these companies will be able to succeed in improving R&D productivity.

In announcing its integration with Wyeth, Pfizer said it will operate through “patient-centric” business units in its two major areas: biopharmaceuticals and diversified businesses. It formed two R&D groups in biopharmaceuticals, one focused on small molecules and related modalties (the PharmaTherapeutics Research Group) and one on larger molecules and vaccines (the BioTherapeutics Research Group). The individual units within these two research organizations are led by chief scientific officers, who will act as single points of accountability for delivering proofs-of-concept for development.

In acquiring a full stake in Genentech earlier this year, Roche said it hoped to continue its successful relationship with Genentech in drug innovation by allowing Genentech to operate as an independent research and early-development center within Roche, seeking cross-fertilization of technologies and expertise between the two companies as a vehicle for innovation.

As it waits for its acquisition of Schering-Plough to be finalized, Merck announced a new structure for Merck Research Laboratories. Merck says the structure is designed to foster innovation and create greater accountability at all stages of research and development through two core functions: (1) discovery and preclinical development and (2) clinical development and regulatory affairs. In addition, a new central franchise structure focused on portfolio management will be aligned with the company’s global human health division. Also, the new Merck Research Laboratories will include a worldwide licensing group.

The impetus behind M&A activity often leaves companies in a “Catch-22” situation, a problem not unique to the pharmaceutical industry. On one hand, greater critical mass is required to fund product development, but as organizations increase in size, size itself can stifle innovation. Let’s see if the pharmaceutical industry is up to the task in overcoming that challenge.

A prime benefit of the acquisition is that it gives sanofi a portfolio of new vaccines in development, said Christopher A. Viehbacher, the company’s CEO, in a press release. This emphasis on biological medicines was a major reason behind Roche’s (Basel) purchase of Genentech (South San Francisco, CA), Merck’s (Whitehouse Station, NJ) acquisition of Schering-Plough (Kenilworth, NJ), and Pfizer’s (New York) purchase of Wyeth (Madison, NJ). The sanofi–Shantha deal also provides more evidence that Asia and emerging markets are where it’s at.

Several factors should make the transition a smooth one. For starters, sanofi aventis is no stranger to large-molecule production. In 2008 alone, the company’s vaccines division, Sanofi Pasteur, produced more than 1.6 billion doses of vaccines to protect against 20 diseases.

What’s more, sanofi is buying a majority stake in Shantha from a subsidiary of Mérieux Alliance (Lyon), which has its origin in Institut Mérieux (Lyon) just as Sanofi Pasteur does. Alain Mérieux, chairman of the Mérieux Alliance, will chair a strategic committee to oversee the acquisition. Mérieux’s stewardship will surely bridge any cultural gaps there might be between sanofi and Shantha, but the companies’ common heritage makes me doubt that a clash would arise.

The New York Times suggested that Roche’s acquisition of Genentech would be relatively easy because of the two companies’ long history together. I’d expect smooth sailing for sanofi and Shantha, too. Let’s see whether the deal brings sanofi even closer to the top of the pharmaceutical-industry pyramid than it already is.

Wyeth’s chairman, Bernard Poussot, stated in a release the deal will bring added resources to the company’s biopharmaceutical division as well as to its human, consumer, and animal healthcare divisions. But some industry observers have speculated that Pfizer may sell off Wyeth’s consumer healthcare units. Last week, the European Commission approved the $68 billion deal but required the companies to divest its animal healthcare businesses.

The dwindling number of new chemical entities and the shrinking number of small-molecule blockbusters have made expansion into biologics a necessary strategy. Still uncertain, however, is the effect these shifts will have in employment. Observers have speculated whether the Pfizer-Wyeth deal will include a repeat of the job cuts Pfizer imposed after its mergers with Warner-Lambert in 2000 and Pharmacia in 2003. Pfizer claims the Wyeth deal will be different. The focus, it says, is on building a strong biopharmaceutical unit, not cutting costs. Job cuts will be relatively minimal at 15% (or 20,000 jobs), and the number of sites will most likely be reduced from 46 to 41.

Perhaps the greatest uncertainty is whether the Wyeth deal will echo results from the Warner Lambert agreement, under which Lipitor became the world’s best-selling drug, or will it flake like the Pharmacia deal, under which Celebrex nose-dived Pfizer’s stock?

PhRMA represents innovator-drug companies and its core membership, although not restricted to, primarily consists of the large pharmaceutical companies. PhRMa says it it is forming the committee to address the particular issues facing smaller companies, including the impact public policy may have on this sector. David Holveck, CEO of Endo Pharmaceuticals, will chair the committee. Additional committee members have yet to be selected.

“Specialty pharmaceutical companies, are in many ways, impacted very differently be federal legislative and regulatory proposals than large PhRMA member companies,” said Holveck in a PhRMA press release. “Now more than ever, we need to be proactive as the industry continues to transform. This new committee will focus on developing solutions to policy issues that are most important to smaller companies.”

PhRMA’s decision to form a committee to provide a voice for small companies is a good one as it shows an understanding of the important role that these companies play in drug development for the industry as a whole and as partners for their Big Pharma brethen. Big Pharma, no doubt, will continue to be the dominant financial force in the industry. The top 15 pharmaceutical companies accounted for 65% of the sales of the US prescription drug market in 2008 and more than 50% of the global market, according to IMS data. But the future of the pharmaceutical industry is increasingly being shaped by dynamics in which smaller companies play a significant role. The erosion of the blockbuster model and the ensuing focus on developing specialized drugs or more targeted therapeutic agents for niche patient populations is a paradigm that fits smaller companies, many of which carve out their spot in the marketplace using a specialized-drug approach. IMS projects that approximately 50–60 new chemical or biologic products are expected to be launched during the next two years, and about two thirds of these products will be specialist-driven. Sales of specialist-driven drugs are projected to increase 8–9% in 2009 and contribute 67% of total pharmaceutical industry growth, according to IMS. At the same time, external collaborations, whether among Big Pharma and biopharmaceutical companies or among biotechnology companies, is significant. Financing in the US biotechnology sector through partnerships and external collaborations was $20 billion in 2008, only slightly down from $22.4 billion in 2007, according to a recent analysis by Burrill and Company.

Roche’s defection from PhRMA to BIO is emblematic of the larger trend toward broadening drug development from small molecules to biologics. Roche’s strategic focus on biologics was punctuated by its $47-billion acquisition of Genentech this year, and this emphasis on biologics is also reflected in other large-scale acquisitions. Some notable recent deals with a biologic component include Pfizer–Wyeth ($68-billion, pending acquisition), Merck-Schering Plough ($41 billion, pending), AstraZeneca-MedImmune ($15.6 billion, 2007), Novartis-Chiron ($5.4 billion, 2006), and Merck-GlycoFi ($400 million, 2006). Growth in biologic-based drugs are projected at 11-12% in 2009, far outpacing the projected growth of 2.5–3.5% (on a constant dollar basis) in the global pharmaceutical market as a whole, according to IMS.

The ability of the pharmaceutical industry to adapt to these changes both as individual companies and aggregately as an industry in policy formation and implementation is critical. Let us hope that it is up to the challenge.

Driving to the office today, I heard a talk by Bob Franks, president of the Healthcare Institute of New Jersey, on the local radio station 101.5FM. Although New Jersey spent $7 billion on R&D in 2008, said Franks, the state stands a chance of losing its stance as the pharma capital of the US—and really of the world—in the coming years. Not only are China, Singapore, and Ireland taking R&D as well as manufacturing dollars out of the state, but New Jersey-based pharmaceutical and biotechnology companies also face stiff competition close to home.

Massachusetts, said Franks, is becoming a top competitor because of the way it’s leveraging its private–academic sector relationships. Many New Jersey universities and colleges, including Rutgers, have been reluctant to listen to the private sector to find out what types of courses and skills need to be taught to prepare next generations of scientists for today’s life-science jobs, according to Franks. Massachusetts, however, he says, is capitalizing on this by pushing university–private sector partnerships. The success of pharma is innovation, said Franks, and without more support for education in this high-tech, innovative industry, New Jersey’s position as the globe’s pharmaceutical headquarters could easily fall.

Another obstacle facing the pharma sector in this state is New Jersey’s flailing economy. Even though the recession is affecting the entire country, this state (along with New York and California) is far worse off than many others in the US when it comes to budget deficits. Facing a potential budget deficit of $6 to $10 billion in 2010, Franks said many companies may not feel comfortable with the future of this state’s economic environment.  Because R&D requires many years of commitment—10-15 years in most cases—companies are becoming less eager to stake their roots—or to stay—in New Jersey. The cost of living here doesn’t help matters. For the biotechnology industry, this potential loss of firms and jobs is critical.

To remain on top, New Jersey needs to pay serious attention to its pharma sector—the largest of the state—and to make sure the sector has the economic and academic support it needs. The Roche-Genentech merger will base its biotech R&D operations in Nutley, NJ, and that will help, says Franks,  but more must happen to make sure the state’s pharma industry isn’t lost.

In response to the swine-flu outbreak, the European Medicines Agency (EMEA) last week authorized the use of Tamiflu (oseltamivir) capsules up to two years after the drug’s prescribed expiration dates. EMEA’s Committee for Medicinal Products for Human Use (CHMP) specifically extended the shelf-life of Tamiflu 75 mg, 45 mg, and 30 mg hard capsules from 5 to 7 years.

Here’s the background: According to the CHMP report, there are currently two classes of antiviral drugs available to treat influenza: adamantane inhibitors (amantadine and rimantadine) and neuraminidase inhibitors (oseltamivir and zanamivir). Studies of the swine-flu virus detected in humans in Mexico and the US were found to be resistant to amantadine and rimantadine, according to the report, so those antivirals were not reviewed. Instead, EMEA focused on oseltamivir, marketed as Tamiflu by Roche, and zanamivir, marketed as Relenza by GlaxoSmithKline. EMEA worked with the drug manufacturers and other experts to review drug safety reports before making their decision. The goal, according to the report, was to avoid a shortage of potentially effective influenza treatments by making sure expired or soon-to-expire capsules were not discarded. Tamiflu’s potential shortage was most imminent, according to the report.

EMEA’s shelf-life extension of Tamiflu does not extend to the pediatric version of the drug. CHMP, therefore, still plans to investigate the drug’s usage for children under age 1 and for pregnant and breastfeeding women, but in case of emergency, has given guidelines for using Tamiflu to treat these patients. Relenza, which is indicated for treatment of influenza in patients over age 5, according to the document, is also still being researched although it was noted as acceptable for use in pregnant women in the case of a full-blown pandemic.

CHMP also noted that storage conditions for Tamiflu are important for maintaining stability. The capsule boxes must remain stored below 25 °C (77 °F).

I’m glad EMEA made this move—to quickly research and make a decision that could potentially save lives. But it also makes me wonder how many other products’ expiration dates could be extended. From time to time, I’ve been known to take an Advil or Tylenol from my medicine cabinet even if it had expired a few weeks before. I figure the drug can’t go that bad just a few weeks after the expiration date, besides, how many people forget to double-check expiration dates? But looking ahead, maybe some money could be saved here. If drugs last longer than we think they do, we wouldn’t have to throw out unused—and potentially still safe and effective—medication. This possibility may be worth looking into even when a pandemic isn’t present.

See FDA’s viewpoint on these antivirals.