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Corporate Spotlight

Race Oncology Ltd (RAC) is a specialty pharmaceutical company. Its business model is to pursue later stage drug assets, principally in the cancer field. Its important asset is a chemotherapy drug, called Bisantrene. Race Oncology is rediscovering Bisantrene.
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RACE AGREEMENT

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Race agreement with TrueMed for Bisantrene NPP in Israel 

ASX Announcement 17 December 2018


HIGHLIGHTS 

  • NPP distribution agreement with TrueMed in Israel 
  • Profit share agreement based on sales of Bisantrene


17 December 2018: Race Oncology Limited (RAC.AX) is very pleased to announce that it has signed an agreement with Israel-based TrueMed Ltd for distribution and sales of Bisantrene in Israel, under a named patient program (NPP)1.


TrueMed is a pharmaceutical distributor with experience in driving NPPs in Israel.


“We believe that Israel could be an important contributor to future global NPP sales of Bisantrene,” said Race CEO, Peter Molloy. “TrueMed has a unique approach and expertise in NPP, along with a firm belief in the opportunity for Bisantrene in AML, based on their own market research.”


According to TrueMed’s owners and co-CEOs, Shmulik Berkovich and Arie Koren, “TrueMed is proud to partner with Race Oncology to provide access to Bisantrene for patients who need it. Bisantrene’s long and robust development program makesit a potential game-changer and a significant option for those patients deemed appropriate by their treating physicians.”


Under the distribution agreement, Race and TrueMed will share the value of all Bisantrene NPP sales in Israel, with 60% of sales turnover paid to Race and 40% retained by TrueMed.


TrueMed will have the exclusive right to sell and distribute Bisantrene in Israel for NPP use and will source Bisantrene exclusively from Race’s global distribution partner Durbin, in the UK. TrueMed will be responsible for gaining the approval of the Israeli Ministry of Health (IMOH) for local NPP distribution of Bisantrene; sales cannot commence until that approval has been obtained. The agreement will operate for an initial period of three years, after which, it can be terminated with nine months’ notice by either party.


About TrueMed 

TrueMed is a prominent rare disease and specialty care company in Israel, providing a complete local distribution and marketing solution for pharmaceutical partners with unique therapies in specific therapeutic areas. TrueMed stands out in the local market as an innovative company and the partner of choice for innovators with cutting-edge therapies such as Sarepta, Amicus, Lucane, AOP Orphan and other (http://www.truemedtx.com).


About Race Oncology (RAC.ASX) 

Race Oncology is a specialty pharmaceutical company whose business model is to pursue later-stage drug assets in the cancer field that have been overlooked by big pharma. The company’s first asset is Bisantrene, a chemotherapy drug, which was the subject of more than 40 clinical studies during the 1980s and 1990s before the drug was abandoned after the results of a Phase III breast cancer study and a series of pharmaceutical mergers. Bisantrene has compelling Phase II data in acute myeloid leukaemia (AML) and Race is seeking to gain US FDA approval for Bisantrene for AML under the accelerated 505(b)(2) regulatory pathway. Bisantrene is the subject of two recently granted US patents and has been awarded US Orphan Drug designation, along with a Rare Paediatric Disease designation.


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AGM

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PRESENTATION

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RARE PAEDIATRIC DISEASE

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Bisantrene receives ‘Rare Paediatric Disease’ designation from FDA

ASX Announcement 18 July 2018 


HIGHLIGHTS

  • FDA grants Rare Paediatric Disease designation for Bisantrene in childhood AML 
  • Qualifies Bisantrene for potential award of Priority Review Voucher

Wednesday 18 July, 2018: Race Oncology Limited (‘RAC’) is pleased to announce that it has received a letter from the FDA advising that Bisantrene has been granted Rare Paediatric Disease (RPD) designation for treatment of childhood Acute Myeloid Leukaemia (AML)

The RPD designation means Bisantrene has the opportunity to be awarded a Priority Review Voucher (PRV) from the FDA at the time of marketing approval for the designated indication. A PRV grants the holder an accelerated 6-month review of a drug application by the FDA.

To be awarded the PRV, Race will need to conduct a clinical trial in the designated indication (childhood leukaemia) under a US IND (Investigational New Drug) application. The protocol, including the type and number of subjects, endpoint(s) and other parameters, will need to be agreed with the FDA, and the trial results will need to meet the agreed endpoint(s). The commencement date, duration, size and cost of the trial will not be precisely known until the Company has further discussions with the FDA. Upon approval of Bisantrene for the designated indication, the PRV may be awarded by the FDA, but there is no guarantee of the award.

Once awarded, a PRV can be sold to another pharmaceutical company for use with another drug and indication. The accelerated review conferred by the PRV can have very substantial value to some companies and accordingly there is an active secondary market for PRVs. Since 2016, PRVs have been selling in the range of US$110-130 million each (approx. A$150-175 million). More information on the PRV system including secondary market sale prices is available at: http://priorityreviewvoucher.org/

“This is a game-changing outcome for Race that adds substantial value to the Company,” said Race CEO, Peter Molloy.

“We already have clear evidence of efficacy in paediatric AML,” said Mr Molloy, referring to the case reports of two French girls who were successfully treated with Bisantrene during the 1980s and 1990s (see ASX releases of 4 June and 26 June 2018).

“To date, we have focused our clinical development plan on adult AML, which is the largest population of AML patients,” said Race CEO, Peter Molloy. “Now, in parallel to the adult program, we plan to expedite a paediatric program directed towards securing the PRV.”

The value of the PRV is entirely independent and in addition to the value for Bisantrene as a treatment for AML. Race indicated that its current intention is to sell the PRV if awarded.

“Selling the PRV does not affect the overall value of Bisantrene,” said Mr Molloy. “Bisantrene could still be launched, licensed or sold as a treatment for adult and paediatric AML, without any significant diminution of its value as a result of the PRV transaction.”

The RPD designation was granted in response to a submission from Race, which argued that childhood AML can be considered a substantively different disease to adult AML based on genetic markers disproportionately found in childhood AML and therefore that it constituted a “rare paediatric disease”.

The FDA agreed, stating that based on the Company’s submission, Bisantrene meets the requirements for a treatment that indication. Race’s submission included historical clinical efficacy and safety data on Bisantrene in childhood AML.

“Apart from the potential value of the PRV, the FDA designation is important affirmation of the potential clinical value of Bisantrene,” said Mr Molloy.

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APPROVAL

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Bisantrene approval in UK for supply as an unlicensed medicine

ASX Announcement 21 June 2018

21 June 2018: Race Oncology Limited (“RAC”) is pleased to announce that approval has been received from the MHRA* for importation and distribution of Bisantrene as an unlicensed medicine in the UK. The letter from the MHRA was received by Race’s distribution partner, Durbin PLC, on 20 June 2018.

Under MHRA regulations, the supply of unlicensed medicines in the UK is allowed subject to MHRA approval and in response to unsolicited requests from doctors for treating patients with unmet medical needs.

The current approval allows Durbin to import and supply Bisantrene to UK-based doctors and hospitals in response to such requests.

The initial approval is for 75 courses of treatment (14 vials per course), but Durbin can apply for additional approvals as needed.

No further approval is needed to commence supply of Bisantrene in response to physician requests or to invoice hospitals that receive the drug. In the UK, the use of unlicensed medicines is typically funded by the hospital that administers the drug.

The MHRA approval also allows Durbin to supply Bisantrene outside the UK to all 28 other countries in the EEA (European Economic Area), subject to local approval and importation rules in each country. For example, in France, an ATU is required in order to import and supply an unlicensed medicine.

About Bisantrene

Bisantrene is a small-molecule chemotherapy drug related to the anthracyclines, the most frequently prescribed cancer drugs and first line of treatment for many cancers, but has been shown to have greatly reduced cardiac toxicity. Bisantrene was tested in more than 40 clinical studies before it was lost in a series of pharmaceutical mergers in the 1990s. The initial clinical opportunity for Bisantrene is for relapsed/refractory AML patients. Race owns two patents on the drug, both of which have received notice of allowance in the US, and has been granted an Orphan Drug Designation in the US for AML, which confers seven years of market exclusivity in US from date of FDA approval.

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Race cancer drug success in AML reported by French doctors

ASX Announcement 5 June 2018

HIGHLIGHTS 

  • Case report: two girls with relapsed AML successfully treated with Bisantrene. 
  • Bisantrene described as “a novel chemotherapy lost to development, with potential benefits over classical anthracyclines.” 
  • “These findings support renewed investigation of Bisantrene in AML.” 
  • Bisantrene is “therapeutically active, with a unique safety profile that is particularly appropriate for the treatment of paediatric AML.”

Tuesday 5 June 2018: Race Oncology Limited (“RAC”) is pleased to announce a case report describing the successful use of Bisantrene to treat childhood relapsed/refractory AML (Acute Myeloid Leukaemia). The report will be published at a forthcoming oncology conference in France.

The case report describes two girls in France who were successfully treated with Bisantrene in 1984 and 1991. Both remain alive today.

“One of the girls was seven years old when diagnosed with AML in 1984,” said Race CEO, Peter Molloy. “She had relapsed after multiple lines of standard chemotherapy and was treated with one 7-day course of Bisantrene, followed by other chemotherapy.”

“She had a complete response to the treatment, which allowed her to receive a bone marrow transplant. As a result, she’s alive today and the mother of three children,” said Mr Molloy.

The other girl was 13 years old when diagnosed in 1990 and also had relapsed after multiple lines of standard chemotherapy. In 1991, she received Bisantrene treatment in combination with two standard chemotherapy agents.

“She also had a complete response, which allowed her to receive a bone marrow graft,” said Mr Molloy. “Thankfully, she is still alive today and has a three-year old child.”

The authors of the case study report are Prof. Guy Leverger, a leading French haematologyoncologist from the Armand Trousseau children’s hospital in Paris, and Prof. Yves Bertrand, also a leading haematology-oncologist, from the Institute of Paediatric Hemato-Oncology in Lyon.

Both doctors were involved in the original Bisantrene studies in France, which were published in the 1980s and 1990s and which contributed to the French marketing approval for Bisantrene.

Prof. Leverger said the findings support renewed investigation of Bisantrene in AML:

“The long-term follow-up with these two salvage paediatric patients I treated decades ago provides interesting insight into a novel chemotherapy lost to development, and with potential benefits over classical anthracyclines,” said Prof. Leverger.

Bisantrene was the subject of more than 40 Phase II clinical studies and showed much promise in AML. However, it was lost in a series of Big Pharma mergers during the 1990s. Race is actively executing a plan to revive Bisantrene and get it approved for sale by the FDA for treatment of AML, including undertaking a pivotal clinical trial.

The case report by the French doctors will be presented as a poster at the International Conference on Leukaemia and Hematologic Oncology in Paris on 21 June 2018.

The poster is titled: “Long-term Survival Case Reports of Two Paediatric Relapsed or Refractory Acute Myeloid Leukaemia Patients Treated with Bisantrene Combination Therapy.”

The report concludes: “Published efficacy results from prior salvage studies of bisantrene in adult and paediatric AML and the long-term case reports presented here, support a renewed interest in its clinical development. Bisantrene is therapeutically active, with a unique safety profile that is particularly appropriate for the treatment of paediatric AML.”

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