Tag Archives: biotechnology

BIO Investor Forum: Supporting Our Clients’ Participation as Panelists, Presenters

Last  week took us to San Francisco for the 10th Annual BIO Investor Forum, an investor conference focused on private and emerging public biotech companies. Multiple clients were involved in the conference either as presenters or panel participants discussing key issues affecting the biotechnology industry. Russo Partners was there to support their activities.

Clients participating on panels included Sutro Biopharma and GlobeImmune. William Newell, chief executive officer of Sutro Biopharma, a company with a biochemical protein synthesis technology platform enabling the design and development of novel proteins that previously have been inaccessible or difficult to produce, provided insight into the future of biosimilars and development strategies on the panel titled Biologics: Billions from BioBetters?

On another panel titled Immunotherapy: Heal Thyself, Timothy Rodell, M.D., president and chief executive officer of GlobeImmune, a company developing therapeutic vaccines for cancer and infectious diseases, discussed the promising future of immunotherapies.

Our clients Anaphore and Flexion Therapeutics also participated in the conference as presenting companies. Brinson Patrick Securities also took advantage of this conference for onsite networking and media opportunities.

At a rich networking event such as BIO Investor Forum, Russo Partners works to maximize our clients’ time spent at the conference by connecting the company executives to key members of the life sciences community.

We look forward to preparing our clients to deliver their “stories” at the next industry event.

Is Social Media a Friend or Foe for Biotechs? It Depends.

The recent policy reversal by Facebook to allow comments on drug companies’ Facebook pages got us thinking about social media and what it means for biotech and pharma companies. Is it good? Is it bad? Neither? Is it safer for a biotech company to just stay out of the social media space entirely?

Our answer to all of these questions: It depends.

When considering a social media program, we first like to ask our clients the question: Which target audience are you trying to reach?

Whenever developing a strategic communications plan, it is imperative to determine your target audience so that you can then choose which outlets will effectively target this population. The same applies to social media forums, as not all social media outlets are created equally.

When deciding whether to use Twitter, Facebook or another social media forum, first decide whether you would like to reach a specific online network of individuals or a consumer audience, in which case it would be smart to utilize Facebook. Perhaps you would like to send a more controlled message to a specific audience of predetermined followers, in which case Twitter may be the medium for you. Your desired outcome determines the optimal social media outlet.

And another key rule of thumb: Just because you can does not necessarily mean that you should. Maintaining, updating and monitoring a social media site takes time, which is a precious resource for all biotech executives. Determine if the time spent is worth the potential upside – oftentimes it is.

So to Facebook or not to Facebook? That is the question. And to that we say: Tell us what you would like to accomplish first, and we will work to make sure your message is delivered effectively to the right audience.

A Congratulations to Amira Pharmaceuticals

Two weeks ago, a Russo Partners client of multiple years, Amira Pharmaceuticals, made headlines as its fibrotic program were at the center of the latest acquisition in Bristol-Myers Squibb’s (BMS) ‘String of Pearls’ strategy.

The San Diego-based small molecule company was acquired for $325 million upfront, and up to an additional $150 million in milestones. The lead asset in the acquisition was its Phase 1 program that targets the lysophosphatidic acid 1 (LPA1) receptor for potential treatment of fibrotic diseases, such as idiopathic pulmonary fibrosis and systemic sclerosis.

When Russo Partners began working with the company, we were charged with finding a way to tell the company’s story that led with the then preclinical LPA1 program. Many were surprised when the company would have little interest in discussing its lead clinical programs, including one partnered with GlaxoSmithKline, in larger disease areas. We aimed to tell the story of the early-but-promising program in an area of significant unmet need through top industry publications to demonstrate its strength and potential value.

Through a highly targeted media outreach approach, we raised awareness and interest in Amira’s early stage programs throughout the investment and partnering communities, ultimately helping the company catch the eye of pharmaceutical giant BMS. In a statement at the time of the acquisition, Elliott Sigal, executive vice president, chief scientific officer and president, Research and Development, Bristol-Myers Squibb, said that BMS “has identified fibrotic diseases as an area of high unmet medical need” and that the acquisition was part of “a highly targeted set of transactions designed to enrich our innovative pipeline with potential medicines to help patients in need.”

Amira’s program targeting autotaxin, a molecular target for the treatment of neuropathic pain and cancer metastases, was also included in the acquisition.

Well done, Amira Pharmaceuticals; we salute your efforts, and we are happy to have been involved in the journey.

Twitter and Biotech, Why it Matters Now

Luke Timmerman of Xconomy recently wrote an excellent article where he explained why Twitter matters now in biotech, and why executives can’t ignore it anymore. In the article, Luke explains his initial hesitation in using the social media tool by saying, “it seemed like a good way to fragment my attention span into a million little pieces by consuming gossip and trivia, diluting the focus needed to produce in-depth biotech news and feature stories on tight deadlines.” Luke then goes on to admit that he was wrong stating, “wrong, wrong, wrong… I do still have some concerns about what real-time connectivity is doing to humanity… I’ve come around to the idea that Twitter, used wisely, has potential to be a great force for good in biotech.”

Check out Luke’s article in Xconomy in its entirety to read his analysis of Twitter and its use in the biotechnology industry.

Biopharmaceuticals, Social Media and the FDA – What can we say?

Social media is a great tool for getting your company’s message across and helping to market your products, but, as we all know, in the biopharmaceutical industry there are limitations on what you say and how you say it. This is most evident when you look at how closely the FDA regulates commercials and magazine advertisements for drugs and biologics.  So what is the FDA’s stance on social media, and what regulations have they put in place to protect consumers and the biopharmaceutical companies?

The FDA has been planning to release guidelines for social media outlets such as YouTube, Twitter and Facebook, but they have yet to do so. They had scheduled to release guidance by the end of 2010, but the FDA missed its target date and moved it to the end of March 2011. But again, the target date has come and gone with no word  on when the industry can expect the guidelines for social media do’s and don’ts.

While we wait for the FDA to establish the long awaited guidance on social media, it is hard for companies in the biopharmaceutical industry to sit back and ignore the growing popularity and success of online sharing and networking sites. In order to help the biopharmaceutical community get involved with social media while avoiding sticky legal situations, the Food and Drug Law Institute (FDLI), made a few suggestions for companies to follow:

  • Transparency is a must. If a message is sponsored, it should say so. If a company gives bloggers a product or any kind of compensation for a mention or review, it should train the bloggers on their responsibility to disclose that information. A tweet or text message can indicate payment or sponsorship by incorporating “#paid” or “#ad.”
  • Companies are responsible for the content on their sponsored sites or comments made on other sites by their staff or paid endorsers. If they allow comments from third parties on their sites, they should consider moderating them before allowing them to be posted. The FDLI suggests using a landing page as a disclaimer to explain the monitoring and posting policies.
  • Companies probably are not responsible for comments made on third-party sites as long as those comments are not made by company officials or compensated individuals. However, if a company corrects something on another site, such as Wikipedia, it could be making itself responsible for continued monitoring of that site.
  • Firms should have policies in place for dealing with adverse events discovered on Facebook, in chat rooms or other social media. This is, perhaps, one of the biggest areas in which guidance is needed.
  • When discussing communicating or marketing through social media, a firm should have an attorney or regulatory person at the table.
  • Given the explosion of phone applications and other mobile devices, companies should be mindful of how an online message will be viewed on those devices. That view could affect the fair balance of risks and benefits.
  • Biopharmaceutical companies should also ask whether they need to use every media available.

**We encourage you to post your thoughts and questions following each entry to help enrich the discussion and help round out the topic. **

Have Some Industry-Specific Terms Become Meaningless?

Over the years as the biotech and pharmaceutical industries have evolved, we have developed many key terms to describe companies, products and new technologies. Many start-up biotech companies are founded on “novel” and “innovative” technologies whose “unique” approach would create a “paradigm shift.” So, how much weight do these terms have now that they have been used for so many years by a rapidly growing industry?

We hear terms like novel and innovative, but do they still drive us to stop and investigate, or have we seen these terms so many times that we have become desensitized such that they no longer evoke that same driving curiosity? Or could it be that there are so many novel and innovative technologies out there that it is overwhelming and difficult to get excited over each one or to even know which ones are actually novel and innovative?

Here is a question that I would like to put to the readers of our blog. Do you think there are terms that are overused in our industry and therefore no longer carry the same weight of importance? If so, which terms are overused in your opinion and how else might you convey the same concept with another term or phrase?

**We encourage you to post your thoughts and questions following each entry to help enrich the discussion and help round out the topic. **

 

Softening the Downside of Uncertain News: Part 4

Now that we have examined the difference between an approval letter and a Complete Response Letter (CRL), we will take a look at why Salix may have announced their suspicion regarding the receiving of a CRL. Although Salix is a publicly-traded company, and they are required by The Securities and Exchange Commission (SEC) to disclose material information, they are only required to do so when they know the information to be factual and documented. Because they only believed they would be receiving a CRL, based on conversations they had with the FDA, but they did not have any documentation in hand, they were not obligated to disclose this information.

So why did they do it? One reason Salix may have announced their anticipation of a CRL could have been an attempt to decrease the impact of the news on their stock price. After Salix announced the anticipation of a CRL, their stock price dropped around 24 percent, a typical drop in price for this type of news. Another reason they may have announced the anticipated CRL ahead of an actual receipt of the letter was with the intention of being upfront with investors and the public. These reasons are speculative but represent the two most likely scenarios that drove Salix towards this strategy.  

Whether they disclose the news as anticipated or wait until they actually receive the document, the news content itself should have the same impact – in this case, a significant drop in stock price. In their discussions with the FDA, the agency may have made it clear that there were issues that would have to be resolved before a final decision could be rendered.

When it comes to regulatory news regarding the approval of a new drug, it is clear that when it’s not a clear cut approval, no matter when you deliver, the news the result is ultimately the same.

**We encourage you to post your thoughts and questions following each entry to help enrich the discussion and help round out the topic. **