Dear Friends of Aastrom,

There have been many studies over the years highlighting the fact that drug discovery and development is typically a very long, risky, complex and costly process.  It is not uncommon for drug development programs to last a decade or more, beginning with early-stage discovery and research, and progressing through late-stage clinical development, regulatory review and approval.  Within that timeline, companies must continually monitor progress and determine when and whether to expand their focus to include essential commercialization strategies to prepare to bring promising late-stage product candidates to the patients who need them.

Over the past year, Aastrom has initiated a number of important activities to support the future commercialization of ixmyelocel-T, which is currently in Phase 3 clinical trials for the treatment of patients with severe peripheral arterial disease (PAD) and existing tissue loss, and in Phase 2 trials for the treatment of patients suffering with dilated cardiomyopathy (DCM).

As an important step in this process, earlier this year we expanded our executive leadership team by naming Dan Orlando chief commercialization officer. Dan is the first executive at Aastrom to be devoted exclusively to planning and executing our commercialization and business development strategies.  Dan has more than 25 years of commercialization experience. He was previously with Takeda Pharmaceuticals for over 13 years in executive leadership positions in marketing, sales and business development, most recently as vice president, business development, for North and South America.  During his career, he has helped to establish dozens of pharmaceutical brands including, most significantly, Actos®. Under Dan’s leadership, Actos® became the top brand in diabetes.

Since he joined Aastrom, Dan and our entire commercial team have been busy!  To give us essential information about the market opportunity for ixmyelocel-T, the team engaged an independent market research firm to complete qualitative market research studies with physicians and payers.  This market research is providing us with many new insights regarding the use of our regenerative medicine therapy in the treatment of patients with severe PAD.  For example, our research thus far has found that:

  • There is widespread interest in ixmyelocel-T as a treatment option for patients with severe peripheral arterial disease with existing tissue loss.  Physicians feel that they have too-few options for patients in need and also confirm that amputation is a poor treatment option that presents many patients with challenging psychosocial, financial and clinical consequences.
  • Physicians also indicate a strong preference for autologous (patient-specific) cellular therapies, indicating that they feel that products such as ixmyelocel-T might be safer compared to other potential therapies.
  • Both physicians and payers believe that a therapy able to reduce the number of amputations will be a cost-effective treatment option.
  • Many surgeons expressed interest in eventually using ixmyelocel-T in combination with revascularization procedures.
  • These findings, and the results from additional research on the commercial opportunity for ixmyelocel-T, will provide Aastrom and potential partners with a clear sense of the commercial opportunity available with ixmyelocel-T and the strongest and clearest path to maximize that opportunity.  This information will help us prepare our marketing strategy and our clinical and patient education materials and programs.  We are very excited that these early market-research results confirm many of our anticipated value propositions for ixmyelocel-T and that we will be well positioned to reinforce these messages in our marketing and outreach activities.

As we move ahead with our commercial plan for ixmyelocel-T, we haven’t lost sight of our near term goals — to finish clinical development and obtain regulatory approval for ixmyelocel-T.  We continue to work closely with our clinical investigators and the independent steering committee to support enrollment in our pivotal Phase 3 REVIVE clinical trial of ixmyelocel-T in patients with severe PAD.  As we maintain our focus on that important objective, we are also building the commercial capabilities we will need to make ixmyelocel-T a successful product.

With regards,