Dear All,
This Sunday will mark the end of the first half of 2012. I would like to thank you all for the contributions to the success of Pinnacle. As in every organization, at any moment in time, we have had our highs and lows. I do not want that the poor results achieved commercially in the second quarter overcast other significant achievement and advances obtained by our organization this year.
First of all, organizationally we are more solid and better staffed to deal with the challenges and opportunities in our hands: Bob and Sharon, Vandana, Beth and Carlos are all very good and talented additions that are alredy having impact and possitvely contributing to our organization.
Most importantly we made tremendous strides advancing the implementation of our short and long term strategy:
• Expansion of Indications:
o Hired a consultant to help of prioritize the Photofrin pipeline and defined a development road going forward.
o Subbmitted application to the FDA to obtain approval for Cholangio Carcinoma in the USA. If approved, Photofrin will become standard of Care in this indication opening a coomercial opportunity for the product in excess of $150 million dollars.
o Completed audit of the meshotelioma data at U-Penn. We will be requesting FDA guidance in the second half of the year to seek approval for this indication. If approved this will create a $20 million commercial opportunity for Photofrin.
o Began negotiating with the Wisconsing medical School a dose ranging trial for Photofrin in Brain Cancer.
o Conducted an advisory board meeting for Phofrin in Head and Neck to prioritize indications and opportunities in this field.
• Control de Modality
o Signed a global agreement with Inter-Medic for laser. Placed an order for four new lasers at the end of the second quarter. Now we have customized, portable, compact and reliable laser available.
o Signed a US agreement with Medlight to expand the offering of fibers: pretty soon will be filing for Ballon Cathether, Flexible fiber and other customized fibers under Pinnacle trademarks.
• Geographical Expansion:
o Signed agreement with Bioprojet to distribute Photofrin in Europe
o Began conversation with potential Photofrin distributors in China, India, South America and the Middle East. The goal is to complete agreements and file for regulatory approvals in the second half of the year.
• Pricing:
o Increased prices in Canada, Japan and Argentina.
• Solidify existing business in existing indications:
o Conducted PDT day at OSU. Gained recognition by global OL's in PDT for Pinnacle in Photodynbamic Therapy.
o Participated in Advances in Gastroenterology Course in Cornell, DDW, Chest, etc.
o Completed assesment of territories, account targenting and account development strategies. Need to focus on commercial execution in the second half of the year.
o Finalizing contract to pilot five centers of excelence across the US. Again commercial execution is key for the succesful implementation of this program in the second half of this year.
o Ready to star OSU registry in July, all planning, contracts, develoment and software developed. Again focus on execution will be key in the second half of the year.
• Medical Affairs;
o Have a solid and well developed program in this area to conduct trials to support the new indications and expansion of indications, support investigator initiated trials, hired MSL's and completing training of the same.
At the risk of sound as a politician seeking reelection to the office, the question to all and specifically to the sales persons and fellow employees that join us from Aptalis is: ARE WE BETTER OF TODAY THAN 18 MONTHS AGO? see how much have we done in the past 18 months...do our customers know this? are we afraid of facing our customers and let them now all what we've done? do we believe the price is an issue when we have things to show?
We have a superior product and technology, we have recently published clinical data validating our claims in approved indications, we know the shortcomings and failure rate of competing products, we are in a different company committed and supporting the product and technology, don't see a reason to check out and give up!
As we beging the second half of this year we are going to be extremely demanding: we need to execute flawesly and that is the goal to all.
We will conduct during the month of July the second update or LBE for this year: we need this to be a careful exercise. From top line to expenses, down to programs, we need to decide how much are we going to spend, in which programs, how much realistically can we execute, program by program, area by area. this will be a more detailed exercise than the previous terms. Given the first half results it is critical to show responsibility not only in managing the resources, but in assessing how much, when, timing and calendarization. Every functional area will review the update with staff and a package will have to be ready by the end of July for my review. This time we will need to take the timing of expenses very seriously. Gary, Karen and Paul will be coordinating this effort.
Again, thank you all for your contribution to Pinnacle.
Best and Happy Four of July!
This Sunday will mark the end of the first half of 2012. I would like to thank you all for the contributions to the success of Pinnacle. As in every organization, at any moment in time, we have had our highs and lows. I do not want that the poor results achieved commercially in the second quarter overcast other significant achievement and advances obtained by our organization this year.
First of all, organizationally we are more solid and better staffed to deal with the challenges and opportunities in our hands: Bob and Sharon, Vandana, Beth and Carlos are all very good and talented additions that are alredy having impact and possitvely contributing to our organization.
Most importantly we made tremendous strides advancing the implementation of our short and long term strategy:
• Expansion of Indications:
o Hired a consultant to help of prioritize the Photofrin pipeline and defined a development road going forward.
o Subbmitted application to the FDA to obtain approval for Cholangio Carcinoma in the USA. If approved, Photofrin will become standard of Care in this indication opening a coomercial opportunity for the product in excess of $150 million dollars.
o Completed audit of the meshotelioma data at U-Penn. We will be requesting FDA guidance in the second half of the year to seek approval for this indication. If approved this will create a $20 million commercial opportunity for Photofrin.
o Began negotiating with the Wisconsing medical School a dose ranging trial for Photofrin in Brain Cancer.
o Conducted an advisory board meeting for Phofrin in Head and Neck to prioritize indications and opportunities in this field.
• Control de Modality
o Signed a global agreement with Inter-Medic for laser. Placed an order for four new lasers at the end of the second quarter. Now we have customized, portable, compact and reliable laser available.
o Signed a US agreement with Medlight to expand the offering of fibers: pretty soon will be filing for Ballon Cathether, Flexible fiber and other customized fibers under Pinnacle trademarks.
• Geographical Expansion:
o Signed agreement with Bioprojet to distribute Photofrin in Europe
o Began conversation with potential Photofrin distributors in China, India, South America and the Middle East. The goal is to complete agreements and file for regulatory approvals in the second half of the year.
• Pricing:
o Increased prices in Canada, Japan and Argentina.
• Solidify existing business in existing indications:
o Conducted PDT day at OSU. Gained recognition by global OL's in PDT for Pinnacle in Photodynbamic Therapy.
o Participated in Advances in Gastroenterology Course in Cornell, DDW, Chest, etc.
o Completed assesment of territories, account targenting and account development strategies. Need to focus on commercial execution in the second half of the year.
o Finalizing contract to pilot five centers of excelence across the US. Again commercial execution is key for the succesful implementation of this program in the second half of this year.
o Ready to star OSU registry in July, all planning, contracts, develoment and software developed. Again focus on execution will be key in the second half of the year.
• Medical Affairs;
o Have a solid and well developed program in this area to conduct trials to support the new indications and expansion of indications, support investigator initiated trials, hired MSL's and completing training of the same.
At the risk of sound as a politician seeking reelection to the office, the question to all and specifically to the sales persons and fellow employees that join us from Aptalis is: ARE WE BETTER OF TODAY THAN 18 MONTHS AGO? see how much have we done in the past 18 months...do our customers know this? are we afraid of facing our customers and let them now all what we've done? do we believe the price is an issue when we have things to show?
We have a superior product and technology, we have recently published clinical data validating our claims in approved indications, we know the shortcomings and failure rate of competing products, we are in a different company committed and supporting the product and technology, don't see a reason to check out and give up!
As we beging the second half of this year we are going to be extremely demanding: we need to execute flawesly and that is the goal to all.
We will conduct during the month of July the second update or LBE for this year: we need this to be a careful exercise. From top line to expenses, down to programs, we need to decide how much are we going to spend, in which programs, how much realistically can we execute, program by program, area by area. this will be a more detailed exercise than the previous terms. Given the first half results it is critical to show responsibility not only in managing the resources, but in assessing how much, when, timing and calendarization. Every functional area will review the update with staff and a package will have to be ready by the end of July for my review. This time we will need to take the timing of expenses very seriously. Gary, Karen and Paul will be coordinating this effort.
Again, thank you all for your contribution to Pinnacle.
Best and Happy Four of July!