Important Updates on DOXIL® Supply Shortage

Throughout the DOXIL^® (doxorubicin HCl liposome injection) supply shortage, we’ve been committed to providing available supply to patients as quickly as possible. Returning a reliable supply of DOXIL^® to the marketplace remains our top priority.

As part of our ongoing commitment to providing available medication to patients, today we are announcing the initiation of an open enrollment process for the DOXIL^® C.A.R.E.S. Physician Access Program, starting 12:00 noon Eastern Time on Friday, May 11, 2012.

Last year, I regrettably noted we closed enrollment to the DOXIL^® C.A.R.E.S. Physician Access Program when manufacturing was suspended at Ben Venue Laboratories (BVL), our third-party manufacturer. Since that time, we’ve been managing a very limited, finite supply. The medication that will be allocated at this time is not new supply and was produced before BVL suspended manufacturing.

We are able to re-open enrollment at this time because some physician allocation requests have changed and freed up product for reallocation. Other physicians indicated DOXIL^® earmarked for patients in the program is no longer needed, or they opted patients out of the program. We’ve met the needs of all physicians who submitted enrollment forms for their patients during the recent DOXIL^® C.A.R.E.S. Physician Access Program re-enrollment process and this latest assessment has allowed us to re-open enrollment for the DOXIL^® C.A.R.E.S. Physician Access Program for patients not currently enrolled.

We encourage physicians who wish to enroll patients to download the materials and instructions here and submit their enrollment forms starting at 12:00 noon Eastern Time on May 11. A few important things to note:

• Physicians may request up to eight cycles of therapy for each patient.
• As with the initial allocation program, all requests will be prioritized on a first-come, first-served basis.
• Since we’re allocating a finite supply of DOXIL^®, we cannot be certain whether there will be a wait list as this will depend on the enrollments we receive. We will continue to allocate any DOXIL^® no longer earmarked as a result of our ongoing utilization until full supply is restored.

Any questions about the DOXIL^® C.A.R.E.S. Physician Access Program can be directed to
1-866-298-5774. For other questions related to DOXIL^®, please contact Janssen Medical Information at
1-800-JANSSEN (526-7736).

Our team continues to aggressively work on returning full supply of DOXIL^® through a variety of options. While BVL continues to estimate late 2012 for DOXIL^® production, we continue to pursue an additional shorter-term option and our long-term effort to transition to alternate suppliers. We will provide updates as soon as we have news to share.

Sincerely,

Rob Bazemore
President
Janssen Products, LP

Enrollment Forms:

DOXIL^® C.A.R.E.S. Physician Access Program Enrollment Form (Editable PDF form. Print and return pages 1-2 only)
DOXIL^® C.A.R.E.S. Physician Access Program Enrollment Form Annotated Guide
DOXIL^® C.A.R.E.S. Physician Access Program Business Associate Agreement

Janssen Products, LP has completed the re-enrollment process initiated on April 9 and can meet all the requests submitted for patients enrolled in the DOXIL^® C.A.R.E.S. Physician Access Program. We will continue to assess utilization and communicate with physicians who have patients enrolled in the program of any updates.

Most importantly, we continue to pursue a variety of options to restore a reliable supply of DOXIL^® to patients and physicians as quickly as possible. Please check this website for additional developments.

As previously announced, manufacturing is suspended at our third-party contract manufacturer, Ben Venue Laboratories (BVL). However, we continue to carefully manage the remaining supply of DOXIL^® (doxorubicin HCl liposome injection) within the DOXIL^® C.A.R.E.S. Physician Access Program. We created this allocation program for physicians to provide an option for current DOXIL^® patients to continue their course of therapy during the shortage.

An important element of the DOXIL^® C.A.R.E.S. Physician Access Program is our ongoing assessment of product utilization within the program. This assessment includes changes in patient status and physician prescribing decisions. This careful tracking of DOXIL^® use has allowed us to reallocate DOXIL^® to meet the enrollment requests of the remaining current DOXIL^® patients on the program wait list (see our January 13 announcement).

We continue our commitment to ensure current DOXIL^® patients enrolled in the program are allocated available supply. The purpose of this communication is to let you know we will be reaching out to physicians with active* program patients, and patients who have completed their initial allocation, to offer the opportunity to re-enroll those who continue to experience clinical benefit with DOXIL^® therapy. As we do not have a reliable and regular supply of DOXIL^® at this time, we are not able to accept new enrollments in the DOXIL^® C.A.R.E.S. Physician Access Program.

Key Actions for Physicians and Patients

• To continue to maximize available product, we will fax instructions and a form titled, “Confirmation of Active Patient Status and Patient Re-enrollment" to physicians with patients in the program starting at noon Eastern time on Monday, April 9, asking them to reconfirm their current allocation for each patient by 8:00 p.m. Eastern time on Monday, April 23, 2012. They can place their order by responding to the monthly re-order form sent by Janssen Products or via their usual purchasing channel.
  • If confirmation is not received or their order is not placed by the April 23 deadline, we regret the unconfirmed enrollment will be opted out of the program so product can be allocated to other patient re-enrollment requests. It is critical for physicians to take this step to reserve their next order for program patients.
  • Physicians with patients receiving allocation will continue to receive a monthly re-order form drawing on their requested allocation. Physicians must confirm their orders each month to continue to receive DOXIL^® therapy for their enrolled patients.
• Additionally, physicians now have the option to re-enroll patients who are receiving or have received allocation through the DOXIL^® C.A.R.E.S. Physician Access Program, regardless of whether they have completed their allocation or are continuing to receive therapy. All requests will continue to be fulfilled on a first-come, first-served basis and we will advise physicians if their patient(s) are placed on a wait list.
  • Physicians who determine a patient is receiving clinical benefit may request up to seven (7) cycles of DOXIL^® to continue the patient’s course of therapy.
  • We encourage patients to follow up with their physicians with any questions about their current allocations and/or about re-enrollment before April 23, 2012. We regret we cannot respond to patient requests for enrollment or individual enrollment status, as only a physician can request DOXIL^® on behalf of patients.
• Regrettably, we are not able to provide estimates for how long it will take for a patient to receive allocation of DOXIL^®. Since no product is currently being manufactured, availability of this supply depends upon utilization of product currently in circulation. Re-enrollment is not a guarantee product will be available within a certain timeframe.

Please contact the DOXIL^® C.A.R.E.S. Physician Access Program at 1-866-298-5774 with questions about the Program. For other questions related to DOXIL^®, please contact Janssen Medical Information at 1-800-JANSSEN (526-7736).

Additional Guidance and Information

By re-allocating the finite amount of DOXIL^® circulating within the DOXIL^® C.A.R.E.S. Physician Access Program to current DOXIL^® patients, we are holding true to a key aspect of this program. We continue to urge physicians to discuss alternative treatment options with their patients, including patients currently receiving DOXIL^® who may be approaching the end of their allocation. Separately, we will continue to assess how to best meet the needs of healthcare professionals who submitted enrollments for new patients as we continue to work on bringing back a reliable supply of DOXIL^® to the healthcare community.

Restoring a reliable supply of DOXIL^® continues to be our most urgent priority and we continue to pursue a variety of options to bring a consistent supply of DOXIL^® back to patients and physicians as quickly as possible. These include shorter-term options to restore supply ahead of the late 2012 timeframe currently estimated by the external contract manufacturer, BVL. We’ll continue to post updates on this website.

*Active = Patients who are enrolled in the program and eligible for drug shipments.

An important announcement was made this week by the U.S. Food and Drug Administration (FDA) about the rare, extraordinary measure of importing a foreign drug as a temporary therapeutic alternative to DOXIL^® (doxorubicin HCl liposome injection). This is promising news for patients and their healthcare teams.

The importation of this product is a temporary alternative put in place by the FDA until a permanent solution to restore DOXIL^® supply is available. While this short-term option exists, all questions regarding Lipodox^™ should be directed either to the FDA or to the manufacturer, Sun Pharma. Links to additional information can be found in the “Resources” section below.

While we recognize the interest of the FDA in facilitating a temporary option for patients, our priority remains working with the FDA to restore a reliable supply of DOXIL^®. We are very encouraged by our continued productive discussions with the FDA to develop options that return DOXIL^® to patients and physicians as quickly as possible.

We realize patients, including those enrolled in the DOXIL^® C.A.R.E.S. Physician Access Program, may have questions about their treatment options in light of this week’s announcement by the FDA. It is important patients talk to their doctors about what course of therapy may be best for them. As noted in the Dear Healthcare Professional Letter posted on the FDA’s website regarding Lipodox^™, it is not an FDA-approved product in the U.S. Further, we do not have information demonstrating this product is therapeutically equivalent to DOXIL^®.

Lipodox^™ will not be distributed through the DOXIL^® C.A.R.E.S. Physician Access Program. For patients who have already been allocated DOXIL^® through the program, their requested course of therapy remains reserved for them. For those enrolled patients who received allocations of DOXIL^® and have since completed their course of therapy, or for patients who have never been treated with DOXIL^® but were submitted for program enrollment by their physicians, we continue to recommend that they speak to their physician about other treatment options. These options may now include the temporary alternate treatment option announced by the FDA, Lipodox^™. And, as noted in our January 13 update, we continually examine the impact of factors on supply utilization to identify any supply that may become available due to changes such as prescribing decisions or patient status.

Importantly, we are making progress toward our long-term solutions to bring DOXIL^® back to the market, via our transition to an identified alternate supplier, additional new external manufacturing capabilities, and other, alternate solutions. To validate and qualify each of these options to produce DOXIL^®, there are many critical steps, each with related timelines -- from tests to confirm the facility can produce DOXIL^® to our exact specifications, to global health authority reviews of any new facilities and sites. We are moving forward as quickly as we can to advance the process.

We are deeply committed to restoring a reliable supply of DOXIL^® to all patients in need, working through all viable channels, in close partnership with the FDA. We will continue to share new developments with you as we have them.

Sincerely,

Rob Bazemore
President
Janssen Products, LP

Resources:

• FDA Drug Shortage Update regarding Lipodox^™:
  http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm
• Copy of Dear Healthcare Professional Letter from Lipodox^™ manufacturer, Sun Pharma:
  http://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM292634.pdf
• E-mail contact for FDA Drug Shortage division: DRUGSHORTAGES@fda.hhs.gov
• Questions related to DOXIL^®: Contact Janssen Medical Information at 1 (800) JANSSEN /
  1 (800) 526-7736

Lipodox^™ is a trademark of Sun Pharma Global FZE

As previously shared, we created the DOXIL^® C.A.R.E.S. Physician Access Program to provide an option for physicians to enroll their current DOXIL^® (doxorubicin HCl liposome injection) patients to continue their course of therapy, as new but intermittent supply became available.

As noted in our December 23 update, we allocated the remaining Ben Venue Laboratories-manufactured supply of DOXIL^® to patients next on the wait list. However, as a result of the impact of other factors on supply utilization, including patient status and changes to prescribing decisions, supply is now available and sufficient to meet the needs of all current DOXIL^® patients who remain on the wait list.

Separately, we will continue to assess how to best meet the needs of healthcare professionals who submitted enrollments for new patients, as we continue to work on bringing back a reliable supply of DOXIL^® to the healthcare community.

As a reminder, we are no longer accepting enrollments into the DOXIL^® C.A.R.E.S. Physician Access Program because we do not anticipate new supply from our third-party manufacturer until late 2012. We continue to urge physicians to discuss alternate treatment options with their patients, including patients currently receiving DOXIL^® who may be approaching the end of their allocation.

Restoring a reliable supply of DOXIL^® continues to be our most urgent priority and we continue to pursue a variety of options to bring a consistent supply of DOXIL^® back to patients and physicians as quickly as possible.

If you have any questions, please contact the DOXIL^® C.A.R.E.S. Physician Access Program at
1 (866) 298-5774. For questions related to DOXIL^®, please contact Janssen Medical Information at
1 (800) JANSSEN (526-7736).

We realize patients and their healthcare teams depend on regular updates about the DOXIL^® (doxorubicin HCl liposome injection) supply situation, and I’ve committed to providing updates on important new developments and vital information as soon as we have it.

Today, we learned Ben Venue Laboratories (BVL), the third-party manufacturer of DOXIL^®, announced an update on the suspension of its manufacturing operations. As part of this update, BVL has indicated it will maintain the site-wide suspension of operations until they have implemented lasting corrective actions for equipment issues. More information about the situation is available on the BVL website at www.benvenue.com.

BVL has notified us that based on current estimates, products manufactured in the North facility where DOXIL^® is produced will not be available until late 2012, and that timelines may be subject to change. Based on this information, we are deeply disappointed to share that we do not anticipate DOXIL^® produced at this facility to be available until November or December 2012, at the earliest.

Restoring a reliable supply of DOXIL^® continues to be our most urgent priority, and we have been seeking the input of those who might be able to expedite alternate and innovative solutions. We continue to make progress and are encouraged by our discussions to date. We also are redoubling our efforts to aggressively pursue short-term options to bring DOXIL^® back to patients and physicians as we continue our longer-term transition to an alternate supplier, which is moving forward as quickly as we can advance the process. While these discussions are ongoing and we don’t have news to share today, we hope to provide an update in early 2012.

Finally, I also want to emphasize information from our December 12 update, where we announced additional, limited quantities of DOXIL^® were being released to the DOXIL^® C.A.R.E.S. Physician Access Program. This limited supply has been successfully allocated, but unfortunately it is all of the remaining DOXIL^® produced by BVL prior to its shutdown.

Until DOXIL^® is produced again, we regret we are no longer accepting new additions to the DOXIL^® C.A.R.E.S. Physician Access Program wait list. We continue to urge physicians to discuss alternate treatment options with their patients, including patients currently receiving DOXIL^® who may be approaching the end of their allocation.

I would like to reiterate my commitment to ensuring a reliable supply of DOXIL^® to all patients in need. You have my word that we’re doing all we can to get DOXIL^® back to patients prior to late 2012 through all viable channels, and we will continue to share new developments as we have them.

I appreciate your time and hope you will continue to check this website for updates.

Sincerely,

Rob Bazemore
President, Janssen Products, LP

CLICK HERE for a Letter to Healthcare Professionals

As I have related in my communications to date, I committed that when we had news to share, we would do so in a timely manner. Today, Janssen Products, LP started contacting physicians with patients enrolled in the DOXIL^® C.A.R.E.S. Physician Access Program about additional limited quantities of DOXIL^® (doxorubicin HCl liposome injection), which will be distributed to patients next on the wait list.

As noted in my November 21 update, the third-party manufacturer of DOXIL^®, Ben Venue Laboratories, Inc. (BVL), announced its temporary suspension of manufacturing and distribution of drug products, including DOXIL^®, as the company focused on conducting a site-wide assessment of the facility.

Despite this challenging development, there was a limited supply of DOXIL^®, which had been produced and was awaiting final quality testing at the time of the suspension that we are now making available. This limited supply represents all of the remaining DOXIL^® previously produced by BVL.

We are aware of some recent information about the quality shortcomings at this contracted supplier of DOXIL^®. We have performed thorough quality reviews of this additional supply of DOXIL^®, which included a review of production procedures and extensive sample testing. Based on these assessments, Janssen Products, LP has now approved release of this supply from BVL for distribution through our patient allocation program.

This modest supply of DOXIL^® will not be sufficient to supply everyone on the wait list. We want to emphasize that this limited product availability does not foreshadow the potential for any additional supply of DOXIL^® in the immediate future, as we have no further information from BVL on when manufacturing will resume at its facility. As I’ve noted before, this is frustrating for us, but it only strengthens our resolve to leave no stone unturned as we look for solutions to bring DOXIL^® back to the market.

All new patient enrollments and additions to the wait list continue to be on hold until we have more information about when production of DOXIL^® supply will resume. During this time, patients will maintain their position on the wait list. Finally, we continue to recommend that physicians discuss alternate treatment options with their patients, including patients currently receiving DOXIL^® who may be approaching the end of their allocation. We also encourage patients to talk to their prescribers about any questions they may have about DOXIL^®.

Restoring a reliable supply of DOXIL^® continues to be the urgent priority for me and our employees. We will continue to share updates as we have them.

Sincerely,

Rob Bazemore
President, Janssen Products, LP

CLICK HERE for a Letter to Healthcare Professionals

In my last message to you on November 9^th, I addressed the supply shortage of DOXIL^® (doxorubicin HCl liposome injection) and promised to communicate additional updates as they came available. As the leader of an organization focused on improving the lives of patients with cancer, I am saddened to share news today that Ben Venue Laboratories, Inc. (BVL), our third-party supplier who manufactures DOXIL^®, announced its temporary suspension of manufacturing and distribution of drug products. Click here to read a posting on the BVL website announcing this news and here to read our related official communication to healthcare providers.

This voluntary decision is a result of an internal BVL review, which indicated that routine preventive maintenance did not happen at a specified time for some manufacturing equipment. This required maintenance included steps to ensure that machinery meet all qualifications before being used again. BVL is halting production to conduct a site-wide assessment to determine the potential impact, if any, and will implement any corrective actions if needed.

This temporary suspension of manufacturing by BVL impacts the production and release of DOXIL^®, which is currently in short supply and not available beyond product already allocated to patients in the DOXIL^® C.A.R.E.S. Physician Access Program. We are not able to estimate timing when DOXIL^® may return to the market as BVL has not provided a commitment on when its manufacturing operations will resume. In light of this situation, patients should speak with their physicians about alternate treatment options.

Those patients who are active and enrolled in the DOXIL^® C.A.R.E.S. Physician Access Program will continue to receive their full course of therapy that has been allocated and set aside specifically for them. Until more information is available about the situation from BVL, we are not accepting new enrollment forms or adding any additional patients to the wait list. If you are currently on the wait list, your place will be held and we will advise on timing of resupply of DOXIL^® when that is possible. For questions related to the status of patient enrollment, please contact the DOXIL^® C.A.R.E.S. Physician Access Program at 1 (866) 298-5774. For questions related to DOXIL^®, please contact Janssen Medical Information at 1 (800) JANSSEN (526-7736).

While we are frustrated by our contract manufacturer's continued manufacturing challenges, it is our obligation to maintain an active role in working with this partner to resume consistent drug supply. Our Janssen employees will continue to partner with BVL with a focus on this goal.

As I expressed in my message on November 9th, although immediate options to resolve these production difficulties at BVL are limited for us, we are ultimately accountable and take full responsibility for the shortage and its ultimate resolution. I also assured you that we are enlisting the help of all those who might be able to expedite the process in the most responsible and effective way possible. To that end, we will continue our work to transition to an identified alternate supplier. And while our goal is to accelerate the transition process where possible, due to the complexity of DOXIL^® manufacture, the transition is likely to occur over an extended period of time. We will also explore all other viable options to produce DOXIL^®.

We are fully committed to bringing DOXIL^® back to the patients and physicians who need it as quickly as possible and will share additional updates on this web site. You'll hear from me again soon. Thank you for listening.

Sincerely,

Rob Bazemore
President, Janssen Products, LP